Vice President, Quality Assurance - GMP
Exelixis•Alameda, CA
•$315,500 - $366,500•Onsite
About The Position
The Vice President, Quality Assurance - GMP is accountable for leading the enterprise GMP Quality Assurance strategy and ensuring GMP QA activities are aligned with the enterprise Quality system across clinical and commercial operations. This role serves as the final decision authority for product disposition while ensuring compliance with global regulatory requirements. As a member of the PSC leadership team, the Vice President, Quality Assurance - GMP partners with clinical and commercial manufacturing, supply chain, logistics, third-party contractors, GCP QA and Quality Systems to ensure GMP requirements are supported, governed and escalated effectively.
Requirements
- 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
- 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
- Comprehensive knowledge of global GMP regulations and Quality systems
- Advanced leadership, analytical and problem-solving skills
- Strong executive communication skills with the ability to translate technical concepts for diverse audiences
- Ability to work with ambiguity and make risk-based decisions
- Ability to align Quality strategies across functions and GxP domains
- Demonstrated ability to lead organizational transformation and change
- Experience interacting with global regulatory agencies and executive governance bodies
- Ability to influence enterprise strategy and organizational decision-making
Nice To Haves
- Advanced degree preferred
- Experience leading Quality organizations through commercialization, expansion or organizational change preferred
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
- Oversee final review and disposition of clinical and commercial materials and products in compliance with global regulatory standards to ensure reliability, quality, efficacy and compliance
- Lead GMP Operations QA, Labeling QA, Audit and Inspection Readiness and associated Quality functions to ensure QA GMP operates at the highest standards
- Partner with the Head of Quality Systems to ensure GMP QA requirements are reflected in Quality systems, governance processes, and continuous improvement activities
- 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
- Ensure effective execution of investigations, root cause analysis, risk assessments, change controls and CAPAs at Exelixis and third-party contractors
- Ensure performance metrics for GMP QA are established, appropriate and regularly assessed
- Identify, evaluate and escalate product quality risks to senior leadership
- Represent GMP Quality in cross-functional governance forums and regulatory interactions
- Lead and develop organizational capability, including talent strategy and succession planning
- Performs other duties as assigned
- Complies with all policies and standards
Benefits
- 401k plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- flexible spending accounts
- discretionary annual bonus program
- opportunity to purchase company stock
- long-term incentives
- 15 accrued vacation days in their first year
- 17 paid holidays including a company-wide winter shutdown in December
- up to 10 sick days throughout the calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
