Exel
Vice President, Quality Assurance - GMP
Alameda, CA · Exec
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DOL prevailing wage, 2026-27 wage year · Industrial Production Managers (11-3051) · San Francisco-Oakland-Fremont, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
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About the role
- The base pay range for this position is $315,500 - $366,500 annually.
- The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.
- The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
Responsibilities
- Lead and oversee the GMP Quality Assurance department
- Drive compliant execution across all GMP QA responsibilities in alignment with the enterprise GMP Quality Assurance strategy
- Lead organizational readiness for GMP inspections at Exelixis and third-party vendors, including regulatory inspections by the FDA and other agencies and audits or inspections by collaboration partners
- Lead Quality input into GMP quality agreements to ensure they support operational needs, compliance expectations and appropriate Quality oversight
- Lead GMP Operations QA, Labeling QA, Audit and Inspection Readiness and associated Quality functions to ensure QA GMP operates at the highest standards
- Oversee labeling governance for clinical and commercial products to support regulatory compliance and consistency
- Partner with PSC functions to establish effective GMP supplier quality and vendor audit programs
- Ensure independent Quality oversight of manufacturing, testing, distribution and external partners
- Partner with the Head of Quality Systems to ensure GMP QA requirements are reflected in Quality systems, governance processes, and continuous improvement activities
- Lead and develop organizational capability, including talent strategy and succession planning
Requirements
- It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
- BS/BA degree in life sciences, engineering or related discipline and a minimum of 21 years of relevant experience
- MS/MA degree in life sciences, engineering or related discipline and a minimum of 19 years of relevant experience
- PhD in life sciences, engineering or related discipline and a minimum of 17 years of relevant experience
Skills
- BS/BA degree in life sciences, engineering or related discipline and a minimum of 21 years of relevant experience; or,
- MS/MA degree in life sciences, engineering or related discipline and a minimum of 19 years of relevant experience; or,
- PhD in life sciences, engineering or related discipline and a minimum of 17 years of relevant experience; or,
- Equivalent combination of education and experience
- Advanced degree preferred
- Extensive experience in biotechnology, pharmaceutical or regulated industry
- Significant leadership experience in GMP Quality Assurance
- Experience with regulatory inspections and global GMP audit programs
- Experience overseeing external manufacturing and supply networks
- Experience leading Quality organizations through commercialization, expansion or organizational change preferred
- Comprehensive knowledge of global GMP regulations and Quality systems
- Advanced leadership, analytical and problem-solving skills
Compensation
- The base pay range for this position is $315,500 - $366,500 annually.
- The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.