Compliance QA Director
Exelixis
June 30, 2026
Remote friendly (Alameda, CA)
United States
Operations
Summary / Role Purpose
- The Compliance QA Director leads GxP inspection readiness to ensure ongoing preparedness for global health authority inspections. Manages regulatory inspections and responses, internal audits and mock inspections, and oversight of corrective and preventive actions to drive timely closure and risk reduction. Serves as a compliance subject matter expert and partners cross-functionally to continuously improve inspection readiness.
Responsibilities
- Lead health authority agency inspections and coordinate responses to observations.
- Set strategy and an annual plan for organizational inspection readiness; drive continuous improvement.
- Lead strategically impactful projects; model change.
- Act as subject matter expert for global regulatory compliance expectations; assess regulatory changes and drive impact assessments.
- Partner with Regulatory Affairs, Clinical Operations, Drug Safety, Pharmaceutical Ops & Supply Chain, and Non-clinical Development to provide GxP compliance guidance.
- Lead cross-functional teams for inspection readiness activities.
- Assess corrective/preventive actions, track/report closure, and provide management visibility to risk.
- Manage internal audits and mock inspections.
- Represent Compliance QA in presentations on audit/inspection readiness initiatives.
- Identify/manage contract auditors, agreements, commitments, assignments, and budget.
- Ensure inspection and audit tools are appropriate.
- Execute external vendor audits as needed under Supplier Quality Management.
Qualifications (Education/Experience)
- Bachelor’s (biology/sciences/STEM) + 13 years relevant experience; or Master’s + 11 years; or equivalent.
- Audit and inspection management experience in pharmaceutical quality compliance/QA.
- 11+ years in GxP quality compliance/QA with leadership in inspection readiness and audits.
Skills/Abilities
- Strong written/oral communication; attention to detail and organization.
- Knowledge of regulatory requirements; applied GxP standards.
- Working knowledge of global regulatory filing inspection preparation (US FDA, EMA, MHRA, PMDA, ANVISA desired).
- Experience supporting health authority inspections (preparation, documentation review, coordination, post-inspection actions).
- Strong influence, negotiation, and collaboration skills; ability to work with ambiguity and complexity.
- Strong Microsoft Office skills.
Travel
- 20%.
Benefits (if explicitly stated)
- 401(k) with generous company contributions; medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus (or sales incentive if field sales); stock purchase; long-term incentives; vacation, holidays (incl. winter shutdown), and sick days.
Application Instruction
- For disability accommodation related to application/recruitment: recruiting@exelixis.com.
- The Compliance QA Director leads GxP inspection readiness to ensure ongoing preparedness for global health authority inspections. Manages regulatory inspections and responses, internal audits and mock inspections, and oversight of corrective and preventive actions to drive timely closure and risk reduction. Serves as a compliance subject matter expert and partners cross-functionally to continuously improve inspection readiness.
Responsibilities
- Lead health authority agency inspections and coordinate responses to observations.
- Set strategy and an annual plan for organizational inspection readiness; drive continuous improvement.
- Lead strategically impactful projects; model change.
- Act as subject matter expert for global regulatory compliance expectations; assess regulatory changes and drive impact assessments.
- Partner with Regulatory Affairs, Clinical Operations, Drug Safety, Pharmaceutical Ops & Supply Chain, and Non-clinical Development to provide GxP compliance guidance.
- Lead cross-functional teams for inspection readiness activities.
- Assess corrective/preventive actions, track/report closure, and provide management visibility to risk.
- Manage internal audits and mock inspections.
- Represent Compliance QA in presentations on audit/inspection readiness initiatives.
- Identify/manage contract auditors, agreements, commitments, assignments, and budget.
- Ensure inspection and audit tools are appropriate.
- Execute external vendor audits as needed under Supplier Quality Management.
Qualifications (Education/Experience)
- Bachelor’s (biology/sciences/STEM) + 13 years relevant experience; or Master’s + 11 years; or equivalent.
- Audit and inspection management experience in pharmaceutical quality compliance/QA.
- 11+ years in GxP quality compliance/QA with leadership in inspection readiness and audits.
Skills/Abilities
- Strong written/oral communication; attention to detail and organization.
- Knowledge of regulatory requirements; applied GxP standards.
- Working knowledge of global regulatory filing inspection preparation (US FDA, EMA, MHRA, PMDA, ANVISA desired).
- Experience supporting health authority inspections (preparation, documentation review, coordination, post-inspection actions).
- Strong influence, negotiation, and collaboration skills; ability to work with ambiguity and complexity.
- Strong Microsoft Office skills.
Travel
- 20%.
Benefits (if explicitly stated)
- 401(k) with generous company contributions; medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus (or sales incentive if field sales); stock purchase; long-term incentives; vacation, holidays (incl. winter shutdown), and sick days.
Application Instruction
- For disability accommodation related to application/recruitment: recruiting@exelixis.com.