The role:The Senior Director, Quality Compliance & Risk Management reports to the Vice President of Quality and provides senior-level leadership for quality compliance, Quality risk management, vendor qualification and oversight, internal and external vendor audit programs, inspection readiness and management, data integrity, and related compliance activities. This individual will work closely with Quality, Clinical Development and Operations, CMC, Regulatory Affairs, Pharmacovigilance, IT, Legal/Data Protection, and other functional teams, as well as external CROs, CMOs, laboratories, consultants, technology providers, and other GxP vendors. The role requires broad GxP expertise, strong independent judgment, and the ability to identify, evaluate, and manage complex or emerging Quality risks as the company progresses through late-stage development and commercialization.
Key responsibilities:- Maintain organizational inspection readiness through ongoing GxP gap assessments, readiness reviews, mock inspections, document and process readiness activities, and tracking of significant gaps and mitigation activities.
- Perform and coordinate data integrity assessments, compliance gap analyses, and quality risk assessments across GxP activities, including evaluation of in-licensed programs and data packages; work with appropriate subject matter experts to characterize risks and develop appropriate mitigation strategies.
- Own the GxP vendor qualification and oversight program, including vendor risk classification, initial qualification, periodic evaluation, re-evaluation, continued qualification, ongoing compliance and performance monitoring, and maintenance of appropriate oversight documentation. Develop and coordinate the risk-based external audit program and global audit calendar, including identification and coordination of qualified internal or external auditors and oversight of significant findings, responses, and corrective actions.
- Develop and execute the internal quality audit program, including risk-based planning, execution, reporting, and follow-up.
- Manage regulatory authority inspections when they occur, including inspection planning, front-room/back-room activities, document requests, subject matter expert preparation, inspector interactions, response development, post-inspection follow-up, and tracking of inspection commitments through closure.
- Establish and maintain practical quality risk management approaches for significant compliance issues and ensure material or systemic risks are appropriately evaluated, documented, communicated, and escalated.
- Provide quality oversight of significant data integrity concerns and collaborate with IT, Legal, and the Data Protection Officer in assessing and managing data breaches or privacy events that may affect GxP systems, data, records, product quality, patient safety, or regulatory compliance.
- Provide Quality oversight of GxP computerized systems and computerized system validation activities and, depending on organizational needs and team capabilities, may assume responsibility for the computerized system validation program.
- Monitor relevant regulatory developments, inspection trends, enforcement activity, and evolving GxP expectations and assess implications for company quality systems and regulated activities.
- Provide senior-level quality judgment on complex compliance and risk matters and flex across quality responsibilities as needed.
Required experience & skills:- Bachelor's degree in life science, quality, engineering, or related discipline.
- Minimum of 15 years of progressive pharmaceutical or biotechnology Quality experience.
- Broad and substantive experience across multiple GxP disciplines, with demonstrated ability to evaluate quality and compliance risks spanning GMP, GCP, GLP/nonclinical, data integrity, computerized systems, and other regulated activities.
- Significant experience in Quality compliance, Quality Risk Management, inspection readiness, GxP auditing, and vendor oversight.
- Demonstrated experience performing GxP gap analyses, compliance assessments, data integrity assessments, and risk-based evaluation and mitigation of identified gaps.
- Significant experience hosting and managing regulatory authority inspections, including inspection preparation, front-room/back-room management, document requests, subject matter expert preparation, inspector interactions, response development, and follow-up.
- Demonstrated experience developing, conducting, or overseeing risk-based internal and external GxP audit programs.
- Demonstrated experience managing risk-based vendor qualification, periodic evaluation, re-evaluation, and continued oversight programs.
- Demonstrated ability to apply quality risk management principles to complex issues, systems, vendors, data, and business decisions.
- Strong independent quality judgment with demonstrated ability to recognize significant or systemic risks, distinguish critical issues from lower-risk concerns, and drive appropriate action and escalation.
- Demonstrated ability to rapidly assess unfamiliar or complex GxP issues, identify the critical quality risks, engage appropriate subject matter experts, and drive risk-based decisions.
- Excellent organizational, problem-solving, prioritization, and time-management skills, with the ability to manage multiple complex activities simultaneously.
- Strong written and verbal communication skills with a collaborative, team-oriented approach.
- Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity.
- Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude.
Preferred experience & skills:- Experience working in a small, rapidly growing, or startup pharmaceutical or biotechnology organization.
- Experience supporting late-stage clinical development, regulatory submissions, and transition to commercial operations.
- Experience evaluating in-licensed programs or data packages and developing risk-based strategies to address identified gaps.
- Experience with computerized system validation, IT Quality, and data integrity sufficient to assume primary responsibility for the computerized system validation program, if needed.
- Experience with regulatory intelligence and evaluation of emerging GxP compliance expectations.
- Prior experience in a broad Quality leadership role requiring meaningful experience across multiple GxP disciplines rather than a single specialized Quality area.
Base Salary Range: $225k - $290k
This role is also eligible for a competitive total rewards package, which may include an annual bonus, equity, and a comprehensive benefits offering.
