Executive GMP QA Leader — Global Quality & Compliance

Regulatory Toolkit; Alameda (CA); On-site; USD 316,000 - 367,000; Full time

Benefits offered by this job

401k plan

Medical/Dental/Vision coverage

Life and disability insurance

Flexible Spending Accounts

Discretionary annual bonus program

Stock options

Vacation days

Paid holidays

Sick days

Job summary

Exelixis is seeking a Vice President, Quality Assurance - GMP to lead the enterprise GMP QA strategy across clinical and commercial operations. This role acts as final decision authority for product disposition and ensures compliance with global regulatory requirements.

As a PSC leadership team member, you will partner with clinical and commercial manufacturing, supply chain, and QA systems to support, govern, and escalate GMP requirements.

Qualifications

• Education: multiple degree paths covering life sciences, engineering or related disciplines.
• Experience: leadership in biotechnology/pharmaceutical GMP QA and regulatory inspections.
• Knowledge/Abilities: global GMP regulations, executive communication, risk-based decision making.

Responsibilities

• Lead and oversee the GMP Quality Assurance department.
• Drive compliant GMP QA execution across all responsibilities.
• Prepare and lead readiness for GMP inspections and regulatory audits.
• Oversee quality agreements and ensure alignment with operational needs.
• Disposition of clinical and commercial materials per global standards.
• Lead QA functions including GMP Operations QA, Labeling QA and Audit readiness.
• Collaborate with Quality Systems to embed GMP QA in governance and processes.
• Oversee labeling governance for regulatory compliance.
• Establish supplier quality and vendor audit programs.
• Ensure independent QA oversight of manufacturing and distribution.

Skills

Leadership

GMP/QA knowledge

Regulatory interactions

Executive communication

Education

BS/BA in life sciences, engineering or related

MS/MA in life sciences, engineering or related

PhD in life sciences, engineering or related

Equivalent education/experience

Advanced degree preferred

Job description

Exelixis is seeking a Vice President, Quality Assurance - GMP to lead the enterprise GMP QA strategy across clinical and commercial operations. This role acts as final decision authority for product disposition and ensures compliance with global regulatory requirements.

As a PSC leadership team member, you will partner with clinical and commercial manufacturing, supply chain, and QA systems to support, govern, and escalate GMP requirements.