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 standards

SUPERVISORY 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 & ABILITIES

Education

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

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 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

#LI-HG1

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. 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.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

If you have a disability and need an accommodation in relation to the recruiting process, please email us at: ApplicantAccommodations@exelixis.com .

WORKING CONDITIONS:

Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

DISCLAIMER: 

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.  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.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.