Interview Guide for

Pharmaceutical Compliance Manager

This comprehensive interview guide will help you efficiently assess pharmaceutical compliance manager candidates through a structured, competency-based approach. Designed with both proven behavioral interview techniques and role-specific evaluations, this guide provides everything you need to identify candidates who can maintain regulatory compliance while supporting business objectives in the pharmaceutical industry.

How to Use This Guide

This interview guide will help you conduct thorough, consistent interviews that identify the most qualified pharmaceutical compliance manager candidates. Use it to:

Create a standardized, fair evaluation process for all candidates
Focus on specific compliance competencies and real-world examples
Compare candidates objectively using the included scorecards

For additional guidance, explore Yardstick's resources on conducting effective interviews and why structured interviews deliver better results. You can also find more compliance-related interview questions in our question library.

Job Description

Pharmaceutical Compliance Manager

About [Company]

[Company] is a [industry] leader dedicated to developing innovative pharmaceutical solutions that improve patient outcomes worldwide. Based in [location], we combine scientific excellence with regulatory rigor to deliver safe, effective treatments to those who need them most.

The Role

The Pharmaceutical Compliance Manager will lead our compliance programs and initiatives, ensuring all operations adhere to relevant regulations and industry standards. This critical role will develop and implement comprehensive compliance strategies that protect patients and the company while supporting business growth objectives. You'll work cross-functionally to build a culture of compliance across the organization.

Key Responsibilities

Develop, implement and monitor comprehensive compliance programs aligned with FDA, EMA, and other relevant regulatory requirements
Conduct risk assessments to identify, prioritize, and mitigate compliance vulnerabilities
Design and deliver compliance training for employees across all levels of the organization
Lead internal investigations related to potential compliance violations
Develop and implement corrective and preventative action (CAPA) plans
Partner with cross-functional teams including R&D, Manufacturing, Legal, Quality, and Commercial to provide compliance guidance
Stay current with evolving regulatory requirements and industry best practices
Report compliance metrics, trends, and recommendations to senior leadership
Manage compliance audits and inspections, ensuring appropriate preparation and follow-up

What We're Looking For

Bachelor's degree in pharmacy, life sciences, law, or related field; advanced degree preferred
5+ years of experience in pharmaceutical/healthcare compliance, preferably in a management role
Comprehensive knowledge of pharmaceutical regulations including FDA regulations, ICH guidelines, and GxP requirements
Strong analytical skills with the ability to assess risk and develop proportionate solutions
Excellent communication and interpersonal skills with the ability to influence at all levels
Proven ability to simplify complex regulatory requirements for various stakeholders
Strong ethical judgment and integrity
Experience developing and delivering compliance training
Collaborative approach with a track record of building partnerships across functions

Why Join [Company]

At [Company], we're committed to improving lives through pharmaceutical innovation while maintaining the highest standards of integrity and regulatory compliance. When you join our team, you'll work alongside dedicated professionals who share your commitment to excellence.

Competitive salary range of [pay range]
Comprehensive benefits including medical, dental, and vision insurance
Retirement plan with company matching
Generous PTO policy and flexible work arrangements
Professional development opportunities and tuition reimbursement
Collaborative, inclusive workplace culture

Hiring Process

We've designed our hiring process to thoroughly evaluate your qualifications while respecting your time:

Initial Screening Interview: A 30-minute conversation with a recruiter to discuss your background and interest in the role.
Regulatory Knowledge Assessment: A 60-minute interview with the hiring manager focused on your understanding of pharmaceutical regulations and compliance strategies.
Case Study Work Sample: You'll analyze a compliance scenario and develop recommendations, which you'll present and discuss in a 60-minute session.
Cross-Functional Competency Interview: A 60-minute panel discussion with stakeholders from Legal, Quality, and Commercial teams to explore how you'd collaborate across the organization.
Executive Alignment Interview: A 45-minute conversation with the head of the department to ensure mutual alignment on expectations and vision.

Ideal Candidate Profile (Internal)

Role Overview

The Pharmaceutical Compliance Manager leads the development and implementation of compliance programs that ensure adherence to regulatory requirements while supporting business objectives. This role requires someone who can translate complex regulations into practical policies, build partnerships across functions, manage compliance risks effectively, and foster a culture of compliance throughout the organization.

Essential Behavioral Competencies

Regulatory Expertise: Demonstrates comprehensive knowledge of pharmaceutical regulations and standards, including FDA regulations, ICH guidelines, and GxP requirements. Stays current with evolving regulations and applies this knowledge to develop effective compliance programs.

Risk Assessment & Management: Systematically identifies, analyzes, and prioritizes compliance risks. Develops proportionate mitigation strategies that protect the organization while allowing for operational efficiency.

Cross-Functional Collaboration: Builds productive relationships with stakeholders across departments. Effectively communicates compliance requirements to technical and non-technical audiences and works collaboratively to develop solutions that meet both regulatory and business needs.

Ethical Leadership: Demonstrates unwavering commitment to ethical principles and integrity. Models ethical behavior and empowers others to make sound compliance decisions. Addresses ethical dilemmas with clarity and courage.

Investigative Acumen: Methodically gathers and analyzes information regarding potential compliance issues. Conducts thorough, objective investigations that identify root causes and inform effective corrective actions.

Desired Outcomes

Develop and implement a comprehensive compliance program that achieves 100% adherence to relevant regulations while maintaining operational efficiency
Reduce compliance-related incidents by 25% within the first year through effective risk assessment, training, and preventative measures
Build strong collaborative relationships with all key departments as measured by stakeholder feedback and successful cross-functional compliance initiatives
Create and deliver compliance training that results in measurable improvements in compliance awareness and behavior across the organization
Establish a robust compliance monitoring system with clear metrics that provide early warning of potential compliance issues

Ideal Candidate Traits

The ideal candidate has extensive knowledge of pharmaceutical regulations with demonstrated success implementing compliance programs that protect organizations while enabling business objectives. They are analytical thinkers who can identify and mitigate risks effectively and communicate complex requirements clearly to diverse audiences.

We seek someone who demonstrates impeccable integrity and ethical judgment, with the courage to address difficult compliance issues directly. The right candidate will be both diplomatic and firm, able to influence without authority and build productive partnerships across functions.

They should be proactive and solution-oriented, continuously seeking to improve compliance processes rather than simply identifying problems. Experience with compliance investigations, CAPA implementation, and regulatory inspections is highly valuable.

The ideal candidate will show a commitment to ongoing learning, adapting quickly to regulatory changes and emerging industry best practices.

Screening Interview

Directions for the Interviewer

This initial screening interview serves as the first evaluation of the candidate's fit for the Pharmaceutical Compliance Manager role. Your goal is to quickly assess whether the candidate has the relevant background, knowledge, and interest to move forward in the interview process.

Ask open-ended questions and listen carefully to the candidate's responses. Note both what they say and how they communicate complex compliance concepts. Look for evidence that they understand key pharmaceutical regulations and have experience implementing compliance programs.

Best Practices:

Begin with a brief introduction of yourself and [Company]
Explain the role's significance within the organization
Focus on the candidate's most relevant experiences
Assess both technical knowledge and soft skills
Note how clearly they explain complex compliance concepts
Reserve 5-10 minutes at the end for candidate questions
Provide clear next steps in the process

Directions to Share with Candidate

"Today we'll be discussing your background in pharmaceutical compliance, your understanding of key regulations, and your approach to compliance management. I'll ask about your experience and how it relates to our Pharmaceutical Compliance Manager role. We'll leave time at the end for your questions about the position and [Company]."

Interview Questions

Tell me about your experience in pharmaceutical compliance and what attracts you to this role at [Company].

Areas to Cover

Previous compliance roles and responsibilities
Specific pharmaceutical regulations they've worked with
What they know about [Company] and why they're interested
How their experience aligns with our compliance needs
Career goals related to compliance

Possible Follow-up Questions

What areas of pharmaceutical compliance do you specialize in?
What initially attracted you to a career in compliance?
How familiar are you with our product portfolio and compliance challenges?
What aspects of pharmaceutical compliance do you find most interesting?

Describe your understanding of the key regulatory requirements affecting pharmaceutical companies today. How do you stay current with evolving regulations?

Areas to Cover

Knowledge of FDA regulations, ICH guidelines, GxP requirements
Understanding of recent regulatory changes
Methods for staying informed (subscriptions, conferences, networks)
Ability to translate regulations into practical compliance strategies
Global vs. regional regulatory knowledge

Possible Follow-up Questions

What regulatory change has been most challenging to implement in your experience?
How do you prioritize which regulatory updates need immediate attention?
How do you evaluate the impact of new regulations on existing processes?
Can you give an example of how you've implemented a new regulatory requirement?

Walk me through your experience developing and implementing compliance programs. What elements do you consider essential?

Areas to Cover

Structure and components of their compliance programs
Risk assessment methodologies
Training and education approaches
Monitoring and auditing processes
Reporting mechanisms and escalation procedures
Investigation and CAPA processes

Possible Follow-up Questions

How do you measure the effectiveness of a compliance program?
How have you gained buy-in from leadership for compliance initiatives?
What challenges have you faced when implementing compliance programs?
How do you balance compliance requirements with business objectives?

How do you approach compliance risk assessment and prioritization? Please provide a specific example.

Areas to Cover

Methodologies for identifying and evaluating risks
Criteria used for risk prioritization
Resource allocation strategies
Examples of risk mitigation strategies
Results and lessons learned

Possible Follow-up Questions

How do you determine acceptable risk levels?
What tools or frameworks do you use for risk assessment?
How have you handled disagreements about risk priorities?
How often do you reassess compliance risks?

Describe your experience working with cross-functional teams on compliance initiatives. How do you build effective partnerships?

Areas to Cover

Stakeholders they've worked with (R&D, Manufacturing, Quality, Legal, Commercial)
Communication strategies for different audiences
Methods for resolving conflicts
Examples of successful collaborations
Approach to gaining buy-in without direct authority

Possible Follow-up Questions

Which functions do you find most challenging to partner with, and why?
How do you communicate compliance requirements to non-technical stakeholders?
How have you handled resistance to compliance initiatives?
What's your approach when compliance requirements conflict with business goals?

What is your approach to handling a potential compliance violation? Describe a situation where you've led an investigation.

Areas to Cover

Process for receiving and evaluating allegations
Investigation methodology
Documentation practices
Confidentiality and objectivity measures
Root cause analysis and CAPA development
Communication with stakeholders

Possible Follow-up Questions

How do you balance thoroughness with timeliness in investigations?
How do you handle situations where senior leaders may be involved?
What's the most challenging investigation you've conducted?
How do you ensure investigations lead to meaningful improvements?

Interview Scorecard

Regulatory Knowledge

0: Not Enough Information Gathered to Evaluate
1: Limited knowledge of pharmaceutical regulations; minimal understanding of regulatory frameworks
2: Basic understanding of pharmaceutical regulations; some gaps in knowledge
3: Solid understanding of key pharmaceutical regulations and how they apply in practice
4: Comprehensive knowledge of regulations with nuanced understanding of application and interpretation

Compliance Program Experience

0: Not Enough Information Gathered to Evaluate
1: Minimal experience developing or implementing compliance programs
2: Some experience with compliance programs but primarily in supporting roles
3: Demonstrated experience developing and implementing effective compliance programs
4: Extensive experience creating innovative, effective compliance programs with measurable results

Risk Assessment Skills

0: Not Enough Information Gathered to Evaluate
1: Rudimentary approach to risk assessment; lacks methodical process
2: Basic risk assessment capabilities; somewhat structured approach
3: Strong risk assessment methodology with clear prioritization criteria
4: Sophisticated risk assessment approach balancing compliance needs with business realities

Communication Skills

0: Not Enough Information Gathered to Evaluate
1: Difficulty explaining compliance concepts; overly technical or unclear
2: Adequately communicates compliance information but could be more effective
3: Clearly communicates complex compliance concepts to different audiences
4: Exceptionally skilled at translating complex requirements into understandable guidance

Desired Outcome: Develop comprehensive compliance program

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Lacks experience or strategy for comprehensive program development
2: Likely to Partially Achieve Goal - Has some relevant experience but approach may have gaps
3: Likely to Achieve Goal - Demonstrated ability to develop effective compliance programs
4: Likely to Exceed Goal - Exceptional track record of creating industry-leading compliance programs

Desired Outcome: Reduce compliance-related incidents

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Reactive approach to compliance without preventative focus
2: Likely to Partially Achieve Goal - Some preventative strategies but may miss root causes
3: Likely to Achieve Goal - Strong preventative approach with effective monitoring systems
4: Likely to Exceed Goal - Proven history of significantly reducing compliance incidents

Desired Outcome: Build cross-functional relationships

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Limited collaboration skills or experience
2: Likely to Partially Achieve Goal - Some collaboration experience but may struggle with difficult stakeholders
3: Likely to Achieve Goal - Demonstrated ability to build effective partnerships
4: Likely to Exceed Goal - Exceptional relationship-building skills with all levels and functions

Desired Outcome: Create effective compliance training

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Limited training development or delivery experience
2: Likely to Partially Achieve Goal - Some training experience but approach may lack innovation
3: Likely to Achieve Goal - Proven ability to develop and deliver effective training
4: Likely to Exceed Goal - Creative, impactful training approach with measurable results

Desired Outcome: Establish robust compliance monitoring

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Limited monitoring experience or understanding
2: Likely to Partially Achieve Goal - Basic monitoring approach without sophisticated metrics
3: Likely to Achieve Goal - Well-developed monitoring strategy with meaningful metrics
4: Likely to Exceed Goal - Innovative monitoring systems that provide predictive insights

Hiring Recommendation

1: Strong No Hire - Significant gaps in experience or knowledge
2: No Hire - Does not meet key requirements or cultural fit
3: Hire - Meets requirements and likely to succeed in role
4: Strong Hire - Exceptional candidate who exceeds requirements

Regulatory Knowledge Assessment

Directions for the Interviewer

This interview focuses on evaluating the candidate's depth of understanding of pharmaceutical regulations and their ability to apply this knowledge to real compliance challenges. As the hiring manager, you'll assess whether the candidate has the technical expertise needed for this role.

Probe beyond theoretical knowledge to understand how the candidate has applied regulatory requirements in practice. Look for evidence that they can interpret regulations appropriately, assess their impact on business operations, and develop practical compliance strategies.

Best Practices:

Begin with broader regulatory questions before diving into specifics
Ask follow-up questions that require application of knowledge
Present scenarios that test judgment and interpretation
Assess their awareness of recent regulatory developments
Evaluate how they simplify complex regulations for different audiences
Look for a balanced approach that protects the organization while supporting business goals
Reserve time for questions about your compliance environment
Provide a realistic overview of the compliance challenges at [Company]

Directions to Share with Candidate

"Today we'll be discussing your knowledge of pharmaceutical regulations and compliance requirements. I'll ask about specific regulations, how you've applied them in practice, and how you approach compliance challenges. This will help us understand your technical expertise and problem-solving approach. We'll leave time at the end for your questions about our compliance environment."

Interview Questions

Describe your experience with FDA regulations, particularly cGMP, Pharmacovigilance, and Promotional requirements. What are some common compliance challenges with each?

Areas to Cover

Specific knowledge of 21 CFR Parts 210, 211, adverse event reporting, and promotional compliance
Experience implementing these regulations in practice
Common pitfalls and how to avoid them
Recent regulatory changes and enforcement trends
Risk-based approaches to compliance in these areas

Possible Follow-up Questions

How have you handled FDA inspections related to these areas?
What systems have you implemented to ensure cGMP compliance?
How do you ensure adverse events are properly detected and reported?
What's your approach to reviewing promotional materials?
How do you stay current with FDA guidance and enforcement priorities?

Walk me through how you would implement a new significant regulatory requirement (e.g., GDPR, updated pharmacovigilance requirements) across a pharmaceutical organization.

Areas to Cover

Initial impact assessment process
Cross-functional involvement and communication
Implementation planning and timeline development
Training and awareness approaches
Monitoring and auditing strategies
Documentation and evidence of compliance

Possible Follow-up Questions

How do you prioritize implementation steps?
How do you handle resistance from business units?
What metrics would you use to track implementation progress?
How do you manage implementation with limited resources?
How do you validate that implementation was effective?

How do you interpret and apply regulations that have ambiguity or allow for different approaches? Provide a specific example.

Areas to Cover

Process for researching regulatory intent
Consultation with experts or authorities
Risk-based decision-making framework
Documentation of rationale
Communication with stakeholders
Monitoring and adjustment as needed

Possible Follow-up Questions

What resources do you consult when facing regulatory ambiguity?
How do you build consensus when there are different interpretations?
How do you document your decision-making process?
How have you handled situations where your interpretation was challenged?
What's your approach when guidance changes after you've implemented a solution?

Describe a situation where you identified a significant compliance gap in your organization. How did you approach remediation?

Areas to Cover

How the gap was identified
Risk assessment and prioritization
Development of remediation plan
Stakeholder communication and management
Implementation challenges and how they were addressed
Verification of effectiveness
Preventative measures for the future

Possible Follow-up Questions

How did you determine the scope of the gap?
How did you gain leadership support for remediation?
What challenges did you face during remediation?
How did you ensure the gap was fully addressed?
What systems did you put in place to prevent recurrence?

How do you balance strict regulatory compliance with business objectives? Give an example of a situation where you had to find this balance.

Areas to Cover

Decision-making framework for compliance vs. business needs
Risk assessment methodology
Stakeholder collaboration
Creative problem-solving approach
Communication strategies
Outcomes and lessons learned

Possible Follow-up Questions

How do you handle pressure from business leaders to take compliance shortcuts?
What factors do you consider when evaluating compliance risks?
How do you communicate compliance requirements to business stakeholders?
What's your approach when compliance directly conflicts with a business goal?
How do you document decisions that involve compliance risk?

How do you assess the compliance culture in an organization, and what steps would you take to strengthen it?

Areas to Cover

Assessment methodologies (surveys, interviews, metrics review)
Key indicators of compliance culture
Strategies for improving awareness and commitment
Leadership engagement approaches
Training and communication initiatives
Measurement of improvement

Possible Follow-up Questions

How do you gain leadership support for cultural initiatives?
What are the most challenging aspects of changing compliance culture?
How do you measure changes in compliance culture?
What incentives have you found effective for promoting compliance?
How do you handle persistent compliance resisters?

Interview Scorecard

Regulatory Expertise

0: Not Enough Information Gathered to Evaluate
1: Surface-level knowledge without depth of understanding or application
2: Basic knowledge of regulations with limited practical application
3: Strong knowledge of key regulations with good practical application
4: Comprehensive regulatory knowledge with sophisticated application and interpretation

Implementation Capability

0: Not Enough Information Gathered to Evaluate
1: Disorganized approach to implementing regulatory requirements
2: Basic implementation methodology but may miss key components
3: Effective, structured approach to regulatory implementation
4: Exceptional implementation strategy that ensures thorough, efficient compliance

Regulatory Interpretation

0: Not Enough Information Gathered to Evaluate
1: Rigid, black-and-white interpretation lacking nuance
2: Some ability to navigate ambiguity but may lack confidence
3: Sound judgment in interpreting and applying ambiguous regulations
4: Sophisticated interpretation balancing regulatory intent, risk, and pragmatism

Compliance Gap Management

0: Not Enough Information Gathered to Evaluate
1: Reactive approach without systematic remediation methodology
2: Basic remediation skills but may lack thoroughness
3: Structured, effective approach to identifying and addressing compliance gaps
4: Comprehensive remediation methodology with preventative focus

Desired Outcome: Develop comprehensive compliance program

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Limited understanding of program components
2: Likely to Partially Achieve Goal - Understands basics but may miss nuances
3: Likely to Achieve Goal - Strong program development knowledge and experience
4: Likely to Exceed Goal - Superior approach to comprehensive program development

Desired Outcome: Reduce compliance-related incidents

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Lacks preventative focus or risk awareness
2: Likely to Partially Achieve Goal - Basic prevention strategies but may be incomplete
3: Likely to Achieve Goal - Effective risk identification and mitigation approach
4: Likely to Exceed Goal - Exceptional preventative strategies with proven results

Desired Outcome: Build cross-functional relationships

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Regulatory-focused without business perspective
2: Likely to Partially Achieve Goal - Some balance but may favor compliance over collaboration
3: Likely to Achieve Goal - Good balance of regulatory expertise and stakeholder engagement
4: Likely to Exceed Goal - Exceptional ability to make compliance a collaborative effort

Desired Outcome: Create effective compliance training

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Overly technical approach without audience awareness
2: Likely to Partially Achieve Goal - Basic training capability but may lack engagement
3: Likely to Achieve Goal - Good ability to translate regulations into effective training
4: Likely to Exceed Goal - Creative, impactful approach to compliance education

Desired Outcome: Establish robust compliance monitoring

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Limited monitoring expertise or systematic approach
2: Likely to Partially Achieve Goal - Basic monitoring capabilities but may lack comprehensiveness
3: Likely to Achieve Goal - Strong monitoring approach with effective metrics
4: Likely to Exceed Goal - Sophisticated monitoring system with predictive capabilities

Hiring Recommendation

1: Strong No Hire - Critical gaps in regulatory knowledge or application
2: No Hire - Insufficient expertise for our compliance needs
3: Hire - Strong regulatory knowledge with practical application skills
4: Strong Hire - Exceptional regulatory expertise with strategic application

Case Study Work Sample

Directions for the Interviewer

This work sample evaluates the candidate's ability to analyze a compliance situation, identify key issues, develop solutions, and communicate their recommendations effectively. It assesses their practical application of compliance knowledge and problem-solving skills.

Provide the case study materials to the candidate at least 24 hours before the interview. During the session, ask them to present their analysis and recommendations (20-30 minutes), followed by a discussion of their approach and reasoning (30-40 minutes).

The case study should present a realistic pharmaceutical compliance scenario relevant to your organization. It could involve:

A compliance gap identified during an audit
A new regulatory requirement that needs implementation
A potential compliance violation requiring investigation
A compliance risk assessment for a new product or process

Evaluate both the quality of their analysis and how they present and defend their recommendations. Look for practical, risk-based approaches that protect the organization while supporting business objectives.

Best Practices:

Ensure the case study is realistic but not overly complex
Provide sufficient background information
Be clear about expectations and deliverables
Ask challenging questions that test their reasoning
Assess how they handle ambiguity or incomplete information
Evaluate both technical accuracy and business practicality
Note their communication skills and ability to defend recommendations
Consider having 1-2 additional stakeholders participate in the session

Directions to Share with Candidate

"We'd like you to analyze the attached compliance case study and prepare a presentation of your findings and recommendations. You'll have 20-30 minutes to present, followed by 30-40 minutes of discussion.

Please address the following in your presentation:

Your analysis of the key compliance issues and risks
Your recommended approach to addressing these issues
How you would implement your recommendations
How you would measure success
Any assumptions you've made or additional information you would need

We're interested in your problem-solving approach, your application of regulatory knowledge, and how you balance compliance requirements with business considerations."

Case Study Example

Provide the candidate with a written case study that includes:

Scenario: [Company] is planning to launch a new combination product that includes both a drug and a medical device component. The product will be marketed in the US and EU, with potential expansion to other regions. Recent quality testing has identified potential issues with the device component. Additionally, the marketing team has developed promotional materials that make some claims about patient outcomes.

Your Task: As the Pharmaceutical Compliance Manager, you need to:

Identify the key compliance risks associated with this product launch
Develop a risk mitigation strategy
Create a plan for reviewing and approving the promotional materials
Determine what compliance monitoring should be implemented post-launch

Available Information:

Brief description of the product and its intended use
Summary of quality testing results showing device inconsistencies
Sample promotional materials with claims
Basic information about timelines and business priorities

Interview Questions (for discussion after presentation)

Walk me through your risk assessment process. How did you prioritize the compliance risks you identified?

Areas to Cover

Methodology for risk identification and analysis
Criteria used for risk prioritization
Consideration of both regulatory requirements and business impact
Assumptions made and additional information needed
Rationale for focusing on certain risks over others

Possible Follow-up Questions

What additional information would have helped your risk assessment?
How would your assessment change if the product were only for US distribution?
What regulatory guidance did you consider most relevant?
How would you involve cross-functional teams in this risk assessment?
How would you present these risks to senior leadership?

Explain your approach to the device component quality issues. What regulatory requirements apply, and how would you ensure compliance?

Areas to Cover

Knowledge of combination product regulations
Understanding of quality system requirements
Approach to addressing device quality issues
Coordination between pharmaceutical and device teams
Documentation and evidence of compliance

Possible Follow-up Questions

How would you determine if the issue requires notification to regulatory authorities?
What would your approach be if production had already begun?
How would you balance quality concerns with launch timelines?
What testing would you recommend before proceeding?
How would you ensure ongoing quality after launch?

Describe your strategy for reviewing the promotional materials. What process would you implement, and what specific issues did you identify?

Areas to Cover

Knowledge of promotional compliance requirements
Process for promotional review
Specific concerns with the provided materials
Cross-functional involvement
Documentation and approval procedures

Possible Follow-up Questions

Who would you involve in the review process?
How would you address disagreements with the marketing team?
What reference information would you use to evaluate claims?
How would you handle urgent review requests?
What systems would you put in place for ongoing promotional compliance?

How would you implement your recommended compliance monitoring activities? What metrics would you track?

Areas to Cover

Monitoring methodology and frequency
Specific metrics and key performance indicators
Data collection and analysis approach
Escalation procedures for identified issues
Resource requirements and responsibilities

Possible Follow-up Questions

How would you ensure monitoring activities don't burden operational teams?
What would trigger an escalation or intervention?
How would you report monitoring results to leadership?
How would you adjust monitoring based on early findings?
What technology or systems would you leverage?

What challenges do you anticipate in implementing your recommendations, and how would you address them?

Areas to Cover

Potential resistance or resource constraints
Timeline and prioritization challenges
Cross-functional coordination difficulties
Technical challenges
Approaches to overcoming these challenges

Possible Follow-up Questions

How would you handle pushback from business leaders concerned about delays?
What contingency plans would you develop?
How would you leverage existing systems versus developing new ones?
How would you ensure consistent implementation across regions?
How would you maintain compliance focus throughout implementation?

Interview Scorecard

Analytical Skills

0: Not Enough Information Gathered to Evaluate
1: Superficial analysis missing key compliance issues
2: Identified main compliance issues but analysis lacks depth
3: Thorough analysis identifying and prioritizing key compliance issues
4: Exceptional analysis with insightful identification of nuanced compliance considerations

Risk Assessment & Management

0: Not Enough Information Gathered to Evaluate
1: Weak risk assessment methodology or prioritization
2: Basic risk assessment with some gaps in approach
3: Strong risk assessment with clear prioritization and mitigation strategies
4: Sophisticated risk assessment balancing compliance requirements with business needs

Regulatory Knowledge Application

0: Not Enough Information Gathered to Evaluate
1: Limited application of relevant regulations to the case
2: Applied some relevant regulations but missed important considerations
3: Effectively applied relevant regulations with appropriate interpretation
4: Expert application of regulations with nuanced interpretation and creative solutions

Implementation Planning

0: Not Enough Information Gathered to Evaluate
1: Vague implementation approach lacking specificity
2: Basic implementation plan with some gaps or unrealistic elements
3: Comprehensive, practical implementation strategy
4: Exceptional implementation plan with attention to challenges, resources, and stakeholder management

Communication Skills

0: Not Enough Information Gathered to Evaluate
1: Unclear presentation with poor explanation of reasoning
2: Adequately communicated recommendations but could be more effective
3: Clear, well-organized presentation with logical reasoning
4: Outstanding presentation with compelling rationale and effective handling of questions

Desired Outcome: Develop comprehensive compliance program

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Piecemeal approach without systematic program development
2: Likely to Partially Achieve Goal - Some program elements but lacks cohesion
3: Likely to Achieve Goal - Demonstrated ability to develop comprehensive program
4: Likely to Exceed Goal - Exceptional program design with innovation and effectiveness

Desired Outcome: Reduce compliance-related incidents

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Reactive approach without preventative focus
2: Likely to Partially Achieve Goal - Some preventative elements but incomplete
3: Likely to Achieve Goal - Strong preventative approach with monitoring mechanisms
4: Likely to Exceed Goal - Exceptional incident prevention strategy with multiple safeguards

Desired Outcome: Build cross-functional relationships

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Siloed compliance approach without collaboration
2: Likely to Partially Achieve Goal - Some collaborative elements but may create friction
3: Likely to Achieve Goal - Effective cross-functional engagement strategy
4: Likely to Exceed Goal - Outstanding approach to making compliance a collaborative effort

Desired Outcome: Create effective compliance training

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Minimal or ineffective training approach
2: Likely to Partially Achieve Goal - Basic training included but not comprehensive
3: Likely to Achieve Goal - Well-designed training strategy addressing key needs
4: Likely to Exceed Goal - Innovative, targeted training approach with effectiveness measures

Desired Outcome: Establish robust compliance monitoring

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Minimal or ineffective monitoring approach
2: Likely to Partially Achieve Goal - Basic monitoring but may miss key elements
3: Likely to Achieve Goal - Comprehensive monitoring strategy with meaningful metrics
4: Likely to Exceed Goal - Sophisticated monitoring system with predictive capabilities

Hiring Recommendation

1: Strong No Hire - Significant deficiencies in analysis or recommendations
2: No Hire - Does not demonstrate sufficient problem-solving ability for the role
3: Hire - Strong analysis and practical recommendations
4: Strong Hire - Exceptional analysis with innovative, effective solutions

Cross-Functional Competency Interview

Directions for the Interviewer

This panel interview evaluates the candidate's ability to work effectively with stakeholders from different functions. The panel should include representatives from Legal, Quality, and Commercial teams who regularly interact with the Compliance function.

Focus on assessing how the candidate builds relationships, communicates with diverse stakeholders, resolves conflicts, and balances compliance requirements with business needs. Each panel member should evaluate the candidate from their functional perspective.

Best Practices:

Begin with introductions of all panel members
Assign specific questions to different panel members
Focus on behavioral examples rather than hypothetical scenarios
Listen for how the candidate has adapted their approach for different audiences
Note their ability to explain compliance concepts to technical and non-technical audiences
Assess how they handle disagreement or pushback
Look for evidence of collaborative problem-solving
Evaluate their ability to influence without authority
Reserve time for panel members' specific questions
Allow time for candidate questions about cross-functional collaboration

Directions to Share with Candidate

"This interview will focus on how you collaborate with stakeholders across different functions. Our panel includes representatives from Legal, Quality, and Commercial who work closely with the Compliance function. We'll ask about your experience building relationships, communicating with diverse audiences, and balancing compliance requirements with business objectives. We're interested in specific examples that demonstrate your collaborative approach."

Interview Questions

Tell us about a time when you had to collaborate with multiple departments to implement a compliance initiative. What was your approach, and what was the outcome? (Cross-Functional Collaboration)

Areas to Cover

Specific initiative and departments involved
How they engaged stakeholders from the beginning
Communication and coordination methods
Challenges encountered and how they were addressed
How they incorporated different perspectives
Results achieved and lessons learned

Possible Follow-up Questions

How did you gain buy-in from skeptical stakeholders?
How did you handle competing priorities between departments?
What would you do differently if you could do it again?
How did you measure the success of the collaboration?
What feedback did you receive from the departments involved?

Describe a situation where you had to deliver difficult compliance news to business stakeholders. How did you approach the conversation, and how was it received? (Communication Skills, Ethical Leadership)

Areas to Cover

Specific compliance issue and its business impact
How they prepared for the conversation
Communication approach and messaging
How they addressed concerns or resistance
Follow-up actions and relationship management
Outcomes and lessons learned

Possible Follow-up Questions

How did you balance being firm on compliance while maintaining the relationship?
What alternatives did you present to the stakeholders?
How did you involve the stakeholders in finding solutions?
How did this impact your relationship with these stakeholders going forward?
What would you do differently next time?

Tell us about a time when compliance requirements seemed to conflict with business objectives. How did you resolve this tension? (Risk Assessment & Management, Cross-Functional Collaboration)

Areas to Cover

Specific conflict between compliance and business goals
How they assessed the situation and risks involved
Their process for exploring potential solutions
How they engaged stakeholders in problem-solving
The ultimate resolution and its rationale
Outcomes for both compliance and business objectives

Possible Follow-up Questions

What principles guided your decision-making?
How did you explain your rationale to different stakeholders?
What compromises, if any, were made on either side?
How did you document the decision and its justification?
What was the long-term impact of this resolution?

Give an example of how you've simplified complex compliance requirements to make them more accessible to non-compliance teams. What was your approach? (Communication Skills, Regulatory Expertise)

Areas to Cover

Specific complex requirement they needed to communicate
Their process for breaking down complex information
Tools or methods used (visual aids, guidance documents, etc.)
How they tailored the message to different audiences
Feedback received and adjustments made
Effectiveness of their approach

Possible Follow-up Questions

How did you determine what information was most important to include?
How did you balance simplification with regulatory accuracy?
What have you found most effective in making compliance accessible?
How did you confirm understanding across different teams?
What tools or techniques do you use for different types of audiences?

Describe a situation where you had to influence a decision without having direct authority. What strategies did you use? (Cross-Functional Collaboration, Ethical Leadership)

Areas to Cover

Specific situation and what they were trying to influence
Their assessment of stakeholders and their interests
Influence strategies employed
How they built credibility and trust
Challenges encountered and how they overcame them
Results achieved and lessons learned

Possible Follow-up Questions

How did you identify the key decision-makers and influencers?
What resistance did you encounter and how did you address it?
How did you frame the issue to appeal to different stakeholders?
What would you do differently in a similar situation?
How do you build influence within an organization over time?

Tell us about a time when you had to investigate a potential compliance issue that involved multiple departments. How did you maintain objectivity and cooperation? (Investigative Acumen, Cross-Functional Collaboration)

Areas to Cover

Nature of the compliance issue and departments involved
Their investigation approach and methodology
How they communicated with stakeholders during the process
Challenges to objectivity or cooperation and how they addressed them
Resolution and corrective actions
How they maintained relationships throughout the process

Possible Follow-up Questions

How did you ensure confidentiality while gathering necessary information?
How did you handle conflicting accounts or perspectives?
What did you do when you encountered resistance to the investigation?
How did you communicate findings and recommendations?
How did you ensure follow-through on corrective actions?

Interview Scorecard

Cross-Functional Collaboration

0: Not Enough Information Gathered to Evaluate
1: Works primarily in silo; limited collaborative experience
2: Some collaborative experience but may struggle with difficult stakeholders
3: Effective collaborator who builds productive relationships across functions
4: Exceptional relationship builder who creates strong partnerships and alignment

Communication Skills

0: Not Enough Information Gathered to Evaluate
1: Overly technical or unclear; struggles to adapt message to audience
2: Adequate communicator but may not always tailor approach effectively
3: Clear, effective communicator who adapts style to different audiences
4: Outstanding communicator who translates complex concepts with exceptional clarity

Influence Without Authority

0: Not Enough Information Gathered to Evaluate
1: Limited experience or effectiveness influencing without direct authority
2: Some influence skills but may rely too much on position or rules
3: Effective influencer who builds credibility and persuades with sound reasoning
4: Exceptional ability to gain buy-in through relationship building and strategic approach

Conflict Resolution

0: Not Enough Information Gathered to Evaluate
1: Avoids conflict or becomes adversarial when challenged
2: Addresses conflicts but may struggle with particularly difficult situations
3: Effectively navigates conflicts with a balanced, solution-oriented approach
4: Exceptionally skilled at turning conflicts into opportunities for improvement

Balance of Compliance and Business Needs

0: Not Enough Information Gathered to Evaluate
1: Rigid compliance focus without consideration of business impact
2: Attempts to balance compliance and business but may favor one too heavily
3: Effectively balances compliance requirements with practical business considerations
4: Exceptional ability to find creative solutions that satisfy both compliance and business needs

Desired Outcome: Develop comprehensive compliance program

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Compliance-centric approach without stakeholder engagement
2: Likely to Partially Achieve Goal - Some engagement but may not fully integrate perspectives
3: Likely to Achieve Goal - Collaborative approach to program development
4: Likely to Exceed Goal - Exceptional ability to create programs with cross-functional ownership

Desired Outcome: Reduce compliance-related incidents

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Punitive approach that may drive issues underground
2: Likely to Partially Achieve Goal - Basic prevention but may miss cultural elements
3: Likely to Achieve Goal - Effective approach to prevention through partnership
4: Likely to Exceed Goal - Cultural transformation approach that drives shared ownership

Desired Outcome: Build cross-functional relationships

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Limited relationship skills or adversarial approach
2: Likely to Partially Achieve Goal - Can build some relationships but may struggle with others
3: Likely to Achieve Goal - Strong relationship builder across functions
4: Likely to Exceed Goal - Exceptional relationship builder who creates advocates

Desired Outcome: Create effective compliance training

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - One-size-fits-all approach without audience focus
2: Likely to Partially Achieve Goal - Basic tailoring but may miss some needs
3: Likely to Achieve Goal - Well-designed training customized to different audiences
4: Likely to Exceed Goal - Innovative training approach with strong stakeholder engagement

Desired Outcome: Establish robust compliance monitoring

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Monitoring approach may create resistance
2: Likely to Partially Achieve Goal - Basic monitoring but may not engage stakeholders
3: Likely to Achieve Goal - Effective monitoring with cross-functional participation
4: Likely to Exceed Goal - Shared ownership monitoring system with broad engagement

Hiring Recommendation

1: Strong No Hire - Significant concerns about collaborative ability
2: No Hire - Does not demonstrate the relationship skills needed for the role
3: Hire - Strong collaborative skills with effective cross-functional approach
4: Strong Hire - Exceptional relationship builder and influencer

Executive Alignment Interview

Directions for the Interviewer

This interview, conducted by the senior leader the role reports to, assesses the candidate's strategic thinking, leadership approach, and alignment with organizational values and vision. It's an opportunity to evaluate whether the candidate will thrive in your organizational culture and can drive compliance as a business enabler rather than just a control function.

Focus on the candidate's philosophy and approach to compliance management, their leadership style, and how they have influenced organizational culture. This interview should be conversational while probing deeply into the candidate's thinking and experience.

Best Practices:

Begin with a brief overview of your compliance vision and approach
Ask questions that reveal the candidate's compliance philosophy
Probe for examples that demonstrate strategic thinking
Assess their ability to influence at senior levels
Evaluate cultural fit and alignment with organizational values
Listen for leadership qualities and management approach
Discuss how they've handled ethically challenging situations
Provide context about your organization's compliance challenges
Be transparent about expectations and organizational realities
Reserve time for the candidate to ask strategic questions

Directions to Share with Candidate

"This conversation will focus on your overall approach to compliance leadership and how you would align with our strategic priorities. I'd like to understand your compliance philosophy, how you've influenced organizational culture, and how you approach leadership. This is also an opportunity for us to ensure mutual alignment and for you to learn more about our vision for the compliance function."

Interview Questions

Describe your philosophy on the role of compliance in a pharmaceutical organization. How do you see compliance contributing to business success? (Ethical Leadership, Cross-Functional Collaboration)

Areas to Cover

Their view of compliance as enabler vs. control function
How they balance compliance requirements with business objectives
Their approach to making compliance a competitive advantage
Examples of how they've aligned compliance with business strategy
How they measure compliance success beyond violations prevented

Possible Follow-up Questions

How has your compliance philosophy evolved over your career?
How have you communicated this philosophy to both compliance teams and business units?
How do you gain leadership support for this approach?
How do you handle situations where others view compliance differently?
How would you adapt your approach to our organization's culture?

Tell me about a time when you had to influence senior leadership on a significant compliance matter. What was your approach, and what was the outcome? (Cross-Functional Collaboration, Ethical Leadership)

Areas to Cover

Specific situation and its significance
How they assessed the situation and stakeholders
Their influence approach and messaging
How they handled resistance or pushback
Outcome achieved and relationship impact
Lessons learned and how they've applied them

Possible Follow-up Questions

How did you prepare for these conversations?
How did you frame the issue to resonate with leadership priorities?
What would you do differently if faced with a similar situation?
How do you maintain relationships while delivering difficult messages?
How do you know when to escalate versus when to find alternative solutions?

How have you transformed a compliance culture in previous organizations? What indicators told you change was needed, and how did you measure success? (Ethical Leadership, Risk Assessment & Management)

Areas to Cover

Signs that indicated cultural issues
Assessment approach and findings
Change strategy and implementation
How they engaged stakeholders at all levels
Challenges encountered and how they overcame them
Metrics used and results achieved

Possible Follow-up Questions

How did you gain buy-in for cultural changes?
What resistance did you encounter and how did you address it?
What were the most effective interventions?
How long did meaningful change take?
How did you ensure sustainability of the changes?

What do you see as the biggest compliance challenges facing the pharmaceutical industry today? How would you prepare our organization to address them? (Regulatory Expertise, Strategic Thinking)

Areas to Cover

Key industry challenges (regulatory, technological, global)
Emerging trends and their potential impact
Strategic approaches to preparing for these challenges
Resource and capability considerations
How they stay ahead of industry developments

Possible Follow-up Questions

Which of these challenges do you think is most underestimated?
How would you prioritize addressing these challenges?
What specific capabilities would you want to develop in our organization?
How do you filter signal from noise in emerging compliance issues?
How would you engage the broader organization in addressing these challenges?

Describe a situation where you had to make a difficult ethical decision with significant business implications. How did you approach it? (Ethical Leadership, Risk Assessment & Management)

Areas to Cover

Specific ethical dilemma and its business context
Their decision-making process and considerations
How they engaged others in the decision
The decision made and its rationale
Outcomes and consequences
Lessons learned and how they've applied them

Possible Follow-up Questions

What principles guided your decision-making?
How did you communicate your decision to stakeholders?
What pushback did you receive and how did you handle it?
Would you make the same decision today?
How has this experience shaped your approach to similar situations?

How do you develop and empower compliance team members? Give examples of how you've helped team members grow. (Leadership, Team Development)

Areas to Cover

Leadership philosophy and management style
Approach to assessing team capabilities and needs
Development strategies and opportunities provided
How they provide feedback and guidance
Examples of team member growth and advancement
Approach to building a high-performing team

Possible Follow-up Questions

How do you identify potential in team members?
How do you balance development with performance expectations?
How do you handle performance issues?
What do you look for when hiring compliance professionals?
How do you promote collaboration within your team?

Interview Scorecard

Strategic Vision

0: Not Enough Information Gathered to Evaluate
1: Tactical focus without strategic perspective
2: Basic strategic understanding but limited vision
3: Clear strategic vision for compliance aligned with business
4: Exceptional strategic thinking with innovative compliance vision

Leadership Approach

0: Not Enough Information Gathered to Evaluate
1: Command-and-control style or overly passive approach
2: Adequate leadership skills but may have development areas
3: Strong, balanced leadership approach that empowers others
4: Exceptional leader who inspires and develops high-performing teams

Ethical Decision-Making

0: Not Enough Information Gathered to Evaluate
1: Rigid or inconsistent ethical framework
2: Sound ethical judgment but may struggle with complex situations
3: Strong ethical compass with balanced, thoughtful approach
4: Exceptional ethical clarity and courage even in difficult circumstances

Organizational Influence

0: Not Enough Information Gathered to Evaluate
1: Limited experience or success influencing at senior levels
2: Some influence ability but may not be strategic in approach
3: Effective influencer who can navigate complex organizational dynamics
4: Exceptional ability to influence across all levels of an organization

Industry Knowledge

0: Not Enough Information Gathered to Evaluate
1: Basic industry understanding without depth
2: Good industry knowledge but may have knowledge gaps
3: Strong, current industry knowledge with good perspective
4: Exceptional industry expertise with forward-looking insights

Desired Outcome: Develop comprehensive compliance program

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Lacks strategic program vision
2: Likely to Partially Achieve Goal - Has vision but may lack execution strategy
3: Likely to Achieve Goal - Strong vision with practical implementation approach
4: Likely to Exceed Goal - Exceptional vision for innovative, effective program

Desired Outcome: Reduce compliance-related incidents

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Reactive rather than preventative focus
2: Likely to Partially Achieve Goal - Basic prevention strategy but may be incomplete
3: Likely to Achieve Goal - Comprehensive prevention approach with cultural elements
4: Likely to Exceed Goal - Sophisticated strategy driving sustained incident reduction

Desired Outcome: Build cross-functional relationships

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Limited relationship approach or overly controlling
2: Likely to Partially Achieve Goal - Basic relationship skills but may not be strategic
3: Likely to Achieve Goal - Strong relationship builder with strategic approach
4: Likely to Exceed Goal - Exceptional relationship architect who transforms perceptions

Desired Outcome: Create effective compliance training

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Traditional approach without strategic vision
2: Likely to Partially Achieve Goal - Solid approach but may lack innovation
3: Likely to Achieve Goal - Strategic training vision with practical implementation
4: Likely to Exceed Goal - Transformative training approach with measurable impact

Desired Outcome: Establish robust compliance monitoring

0: Not Enough Information Gathered to Evaluate
1: Unlikely to Achieve Goal - Basic monitoring without strategic framework
2: Likely to Partially Achieve Goal - Solid monitoring but may lack innovation
3: Likely to Achieve Goal - Strategic monitoring approach with meaningful metrics
4: Likely to Exceed Goal - Industry-leading monitoring framework

Hiring Recommendation

1: Strong No Hire - Significant concerns about strategic alignment or leadership
2: No Hire - Does not demonstrate the strategic or leadership capabilities needed
3: Hire - Strong strategic thinker and leader who aligns with our vision
4: Strong Hire - Exceptional strategic leader who would elevate our compliance function

Debrief Meeting

Directions for Conducting the Debrief Meeting

The Debrief Meeting is an open discussion for the hiring team members to share the information learned during the candidate interviews. Use the questions below to guide the discussion.

Start the meeting by reviewing the requirements for the role and the key competencies and goals to succeed.

The meeting leader should strive to create an environment where it is okay to express opinions about the candidate that differ from the consensus or from leadership's opinions.

Scores and interview notes are important data points but should not be the sole factor in making the final decision.

Any hiring team member should feel free to change their recommendation as they learn new information and reflect on what they've learned.

Questions to Guide the Debrief Meeting

Question: Does anyone have any questions for the other interviewers about the candidate?

Guidance: The meeting facilitator should initially present themselves as neutral and try not to sway the conversation before others have a chance to speak up.

Question: Are there any additional comments about the Candidate?

Guidance: This is an opportunity for all the interviewers to share anything they learned that is important for the other interviewers to know.

Question: How does the candidate's regulatory expertise align with our specific compliance needs?

Guidance: Discuss whether the candidate's knowledge of pharmaceutical regulations is sufficient, particularly in areas most relevant to our products and operations.

Question: How effectively would the candidate balance compliance requirements with business objectives?

Guidance: Consider the candidate's approach to making compliance a business enabler rather than just a control function, and their ability to find practical solutions.

Question: Is there anything further we need to investigate before making a decision?

Guidance: Based on this discussion, you may decide to probe further on certain issues with the candidate or explore specific issues in the reference calls.

Question: Has anyone changed their hire/no-hire recommendation?

Guidance: This is an opportunity for the interviewers to change their recommendation from the new information they learned in this meeting.

Question: If the consensus is no hire, should the candidate be considered for other roles? If so, what roles?

Guidance: Discuss whether engaging with the candidate about a different role would be worthwhile.

Question: What are the next steps?

Guidance: If there is no consensus, follow the process for that situation (e.g., it is the hiring manager's decision). Further investigation may be needed before making the decision. If there is a consensus on hiring, reference checks could be the next step.

Reference Checks

Directions for Conducting Reference Checks

Reference checks are a crucial final step in evaluating the Pharmaceutical Compliance Manager candidate. They provide third-party verification of the candidate's experience, capabilities, and working style, particularly in areas critical to compliance roles where integrity and judgment are paramount.

Before conducting reference checks, ask the candidate to provide 3-5 professional references, preferably including direct supervisors, peers from different functions, and direct reports. Request that the candidate make an introductory connection to help ensure the reference is expecting your call.

Best Practices:

Prepare by reviewing the candidate's resume and interview notes
Identify specific areas you want to verify or explore further
Establish rapport with the reference before asking detailed questions
Use open-ended questions that encourage specific examples
Listen for hesitations or qualifiers in responses
Ask follow-up questions to get complete information
Maintain consistency by asking the same core questions of all references
Take detailed notes and look for patterns across references
Remember that references may be coached, so probe beyond general statements
Thank the reference for their time and insights

Remember that this reference check template can be used multiple times with different references for the same candidate.

Questions for Reference Checks

Please describe your relationship with [Candidate]. How long did you work together, and what was the nature of your working relationship?

Guidance: Establish the credibility of the reference and the context of their relationship with the candidate. Note how long they worked together, their relative positions, and how closely they interacted.

What would you say are [Candidate]'s greatest strengths in the compliance area? Can you provide specific examples that demonstrate these strengths?

Guidance: Listen for concrete examples rather than general statements. Note whether the strengths align with the key competencies for this role, particularly regulatory expertise, risk assessment, cross-functional collaboration, ethical leadership, and investigative acumen.

Can you describe a situation where [Candidate] had to balance strict regulatory compliance with business objectives? How did they approach this challenge?

Guidance: This question targets a critical skill for the Pharmaceutical Compliance Manager role. Listen for evidence of practical judgment, creative problem-solving, and effective stakeholder management. Note whether they maintained compliance while finding business-friendly solutions.

How would you describe [Candidate]'s approach to working with different departments and stakeholders? Can you give an example of how they built effective partnerships?

Guidance: Cross-functional collaboration is essential for this role. Listen for specific examples of relationship-building, influence without authority, and stakeholder management. Note their communication style and effectiveness with different audiences.

Have you observed [Candidate] handling a compliance issue or investigation? How did they approach it, and what was the outcome?

Guidance: This explores their investigative acumen and ethical leadership. Listen for thoroughness, objectivity, and fairness in their approach. Note how they balanced fact-finding with maintaining relationships and confidentiality.

In what areas do you think [Candidate] has the most opportunity for professional growth? How did they respond to feedback in these areas?

Guidance: Listen for self-awareness and learning agility. Note whether the development areas would be concerning for this specific role, and whether the candidate actively works on improvement. Also assess the reference's candor in responding to this question.

On a scale of 1-10, how likely would you be to hire [Candidate] for a compliance leadership role if you had the opportunity? Why?

Guidance: This direct question often yields valuable insights. Listen for enthusiasm or hesitation. Ask follow-up questions to understand the reasoning behind their rating. Anything less than an 8 warrants further exploration.

Reference Check Scorecard

Regulatory Expertise

0: Not Enough Information Gathered to Evaluate
1: Limited knowledge or application of regulatory requirements
2: Adequate regulatory knowledge with some implementation experience
3: Strong regulatory expertise with effective practical application
4: Exceptional regulatory mastery with sophisticated application

Cross-Functional Collaboration

0: Not Enough Information Gathered to Evaluate
1: Struggles to build partnerships; may create resistance
2: Adequate collaborator but may face challenges with certain stakeholders
3: Effective relationship builder who works well across functions
4: Exceptional collaborator who builds strong partnerships at all levels

Ethical Leadership

0: Not Enough Information Gathered to Evaluate
1: Inconsistent ethical judgment or courage
2: Generally sound ethics but may struggle in complex situations
3: Strong ethical compass with good judgment and courage
4: Exceptional ethical leadership that inspires others

Risk Assessment & Management

0: Not Enough Information Gathered to Evaluate
1: Overly risk-averse or insufficient risk awareness
2: Basic risk assessment capabilities with some gaps
3: Strong risk assessment approach with appropriate prioritization
4: Sophisticated risk management balancing protection with business needs

Desired Outcome: Develop comprehensive compliance program

0: Not Enough Information Gathered to Evaluate
1: Limited success developing effective compliance programs
2: Has implemented basic programs but may lack sophistication
3: Demonstrated ability to develop comprehensive, effective programs
4: Track record of creating industry-leading compliance programs

Desired Outcome: Reduce compliance-related incidents

0: Not Enough Information Gathered to Evaluate
1: Limited success in incident reduction
2: Some success but may have gaps in approach
3: Proven ability to reduce incidents through systematic approach
4: Exceptional history of incident reduction with measurable results

Desired Outcome: Build cross-functional relationships

0: Not Enough Information Gathered to Evaluate
1: Limited success building effective relationships
2: Generally good relationships but may struggle with certain stakeholders
3: Strong relationship builder across functions
4: Exceptional relationship builder who transforms compliance perception

Desired Outcome: Create effective compliance training

0: Not Enough Information Gathered to Evaluate
1: Basic training approach without innovation or measured impact
2: Solid training approach but may lack creativity or effectiveness
3: Effective compliance training with good engagement and results
4: Innovative, high-impact training with demonstrated behavior change

Desired Outcome: Establish robust compliance monitoring

0: Not Enough Information Gathered to Evaluate
1: Basic monitoring without sophisticated analysis
2: Reasonable monitoring approach with some effectiveness
3: Strong monitoring systems with meaningful metrics
4: Sophisticated monitoring with predictive capabilities and high impact

Frequently Asked Questions

How should I prepare for using this interview guide?

Review the entire guide and customize it to your company's specific compliance needs. Familiarize yourself with the key competencies and desired outcomes. For the regulatory knowledge assessment, ensure you're prepared to discuss regulations specific to your products and markets. For the case study, select or create a scenario relevant to your organization's compliance challenges.

What if a candidate has strong regulatory knowledge but seems rigid in their approach?

This is a common challenge in compliance hiring. During the cross-functional competency interview, dig deeper into their collaboration style and ability to find balanced solutions. Ask for examples of when they've had to compromise or find creative approaches to compliance challenges. The case study is also valuable for assessing their flexibility and problem-solving approach.

How important is industry-specific experience for this role?

While pharmaceutical industry experience is valuable, the transferability of compliance skills depends on the specific role requirements. Candidates from related regulated industries (medical devices, biotech, healthcare) often transition successfully. Focus on their regulatory foundation, learning agility, and ability to quickly master new requirements. The blog post on hiring for potential offers helpful perspectives on this question.

What's the best way to assess a candidate's ethical judgment?

Look for patterns across multiple interviews. The behavioral questions about ethical dilemmas and difficult decisions provide insights, but also note how candidates approach other questions. Do they demonstrate integrity in how they discuss former employers? Are they transparent about failures and lessons learned? Reference checks are particularly valuable for validating ethical character.

Should we include a written assessment component for this role?

While this guide includes a case study presentation, some organizations add a written exercise to assess the candidate's ability to document compliance issues clearly. This can be valuable for roles heavily involved in policy writing or regulatory submissions. If added, keep the exercise focused and relevant, providing clear instructions and reasonable time expectations.

How can we ensure our compliance hiring process itself follows best practices?

Maintain consistency across candidates, document your evaluations thoroughly, and ensure questions are job-relevant and non-discriminatory. Be transparent about the process and timeline with candidates. Consider having HR review your interview plan. For more guidance, see our article on designing your hiring process.