Vice President, Quality Assurance - GMP
Exelixis
August 31, 2026
On-site
Alameda, CA
Operations
Summary/Job Purpose:
- Lead the enterprise GMP Quality Assurance strategy and ensure GMP QA activities align with the enterprise Quality system across clinical and commercial operations.
- Final decision authority for product disposition, ensuring compliance with global regulatory requirements.
- Partner with manufacturing, supply chain/logistics, third-party contractors, GCP QA, and Quality Systems to support/gov/ escalate GMP requirements.
Responsibilities:
- Lead and oversee the GMP Quality Assurance department.
- Drive compliant execution of all GMP QA responsibilities per enterprise strategy.
- Lead readiness for GMP inspections/audits (FDA and others) for Exelixis and third-party vendors.
- Provide Quality input into GMP quality agreements.
- Oversee final review and disposition of clinical/commercial materials and products.
- Lead GMP Operations QA, Labeling QA, Audit/Inspection Readiness, and related Quality functions.
- Ensure GMP QA requirements are reflected in Quality systems, governance, and continuous improvement (with Head of Quality Systems).
- Oversee clinical/commercial labeling governance.
- Establish GMP supplier quality and vendor audit programs.
- Ensure independent Quality oversight of manufacturing/testing/distribution and external partners.
- Ensure investigations, root cause analysis, risk assessments, change controls, and CAPAs.
- Establish and assess GMP QA performance metrics; identify/escalate product quality risks.
- Represent GMP Quality in governance forums and regulatory interactions.
- Lead and develop organizational capability (talent strategy/succession).
Supervisory:
- Executive leadership, organizational structure, recruiting, performance management, and enterprise Quality leadership team oversight.
Qualifications:
- BS/BA (21+ yrs) or MS/MA (19+ yrs) or PhD (17+ yrs) in life sciences/engineering (advanced degree preferred).
- Extensive biotechnology/pharma/regulated industry experience; significant leadership in GMP QA.
- Experience with regulatory inspections and global GMP audit programs.
- Experience overseeing external manufacturing/supply networks.
- Preferred: leading Quality organizations through commercialization/expansion/organizational change.
Required Skills:
- Comprehensive knowledge of global GMP regulations and Quality systems.
- Advanced leadership, analytical/problem-solving, and executive communication.
- Risk-based decision-making in ambiguity; align Quality strategy across functions/GxP.
- Ability to lead organizational transformation; experience with global regulators and executive governance.
Benefits (as stated):
- 401k with company contributions; medical/dental/vision; life/disability; flexible spending; discretionary annual bonus (or sales incentive for field sales); stock purchase; long-term incentives.
- 15 vacation days first year; 17 paid holidays (incl. winter shutdown); up to 10 sick days.
Application Instruction:
- For disability accommodations in recruiting: ApplicantAccommodations@exelixis.com.
- Lead the enterprise GMP Quality Assurance strategy and ensure GMP QA activities align with the enterprise Quality system across clinical and commercial operations.
- Final decision authority for product disposition, ensuring compliance with global regulatory requirements.
- Partner with manufacturing, supply chain/logistics, third-party contractors, GCP QA, and Quality Systems to support/gov/ escalate GMP requirements.
Responsibilities:
- Lead and oversee the GMP Quality Assurance department.
- Drive compliant execution of all GMP QA responsibilities per enterprise strategy.
- Lead readiness for GMP inspections/audits (FDA and others) for Exelixis and third-party vendors.
- Provide Quality input into GMP quality agreements.
- Oversee final review and disposition of clinical/commercial materials and products.
- Lead GMP Operations QA, Labeling QA, Audit/Inspection Readiness, and related Quality functions.
- Ensure GMP QA requirements are reflected in Quality systems, governance, and continuous improvement (with Head of Quality Systems).
- Oversee clinical/commercial labeling governance.
- Establish GMP supplier quality and vendor audit programs.
- Ensure independent Quality oversight of manufacturing/testing/distribution and external partners.
- Ensure investigations, root cause analysis, risk assessments, change controls, and CAPAs.
- Establish and assess GMP QA performance metrics; identify/escalate product quality risks.
- Represent GMP Quality in governance forums and regulatory interactions.
- Lead and develop organizational capability (talent strategy/succession).
Supervisory:
- Executive leadership, organizational structure, recruiting, performance management, and enterprise Quality leadership team oversight.
Qualifications:
- BS/BA (21+ yrs) or MS/MA (19+ yrs) or PhD (17+ yrs) in life sciences/engineering (advanced degree preferred).
- Extensive biotechnology/pharma/regulated industry experience; significant leadership in GMP QA.
- Experience with regulatory inspections and global GMP audit programs.
- Experience overseeing external manufacturing/supply networks.
- Preferred: leading Quality organizations through commercialization/expansion/organizational change.
Required Skills:
- Comprehensive knowledge of global GMP regulations and Quality systems.
- Advanced leadership, analytical/problem-solving, and executive communication.
- Risk-based decision-making in ambiguity; align Quality strategy across functions/GxP.
- Ability to lead organizational transformation; experience with global regulators and executive governance.
Benefits (as stated):
- 401k with company contributions; medical/dental/vision; life/disability; flexible spending; discretionary annual bonus (or sales incentive for field sales); stock purchase; long-term incentives.
- 15 vacation days first year; 17 paid holidays (incl. winter shutdown); up to 10 sick days.
Application Instruction:
- For disability accommodations in recruiting: ApplicantAccommodations@exelixis.com.