Vice President, Quality Assurance - GMP

SUMMARY/JOB PURPOSE 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.

ESSENTIAL DUTIES/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 standardsSUPERVISORY RESPONSIBILITIES Provide executive leadership for GMP Quality Assurance, including GMP Operations QA, audit, inspection readiness and associated Quality functions

Develop organizational structure, recruit talent and manage performance of direct and indirect reports

Set organizational priorities and align resources to meet business objectives

Partner across functions to achieve organizational goals and ensure compliance

Serve on the enterprise Quality leadership team. providing independent oversight, cross-functional governance, and escalation of Quality-related risks and decisions in partnership with GCP/GVP QA and Quality Systems and Process functions EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIESEducationBS/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

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

Experience leading Quality organizations through commercialization, expansion or organizational change preferred

Knowledge, Skills and Abilities Required:

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…