Operations QA Manager - Commercial

Exelixis • Alameda, CA

8d • $145,000 - $183,000 • Onsite

About The Position

The Operations QA Manager - Commercial is responsible for quality assurance oversight of end-to-end, day-to-day GMP operations at contract manufacturing organizations (CMOs) that produce Exelixis products, including drug substance, drug product, intermediates, raw materials, packaging, and labeling. The role assesses vendor processes, systems, and procedures against established quality standards and regulatory requirements, reviews batch records, and collaborates with Exelixis partners to identify, mitigate, and escalate product risks.

The position develops and maintains QA programs, policies, and procedures to support GMP compliance for commercial and clinical trial materials. It performs record review and disposition, coordinates investigations, oversees GMP documentation, and supports vendor and contract-facility management, validation, change management, and quality systems. The role also monitors relevant regulatory, quality, and scientific developments and contributes to quality and regulatory document review.

This is an onsite position in Alameda, California, with travel as required. The stated base salary range is $145,000–$183,000. Exelixis describes its office as a modern collaborative workspace and provides equipment including dual monitors and ergonomic chairs.

Requirements

• Bachelor’s degree in a related discipline and at least 7 years of related experience; or a master’s degree in a related discipline and at least 5 years of related experience; or a Ph.D. in a related discipline and 0 or more years of related experience; or an equivalent combination of education and experience.
• Experience in the biotech or pharmaceutical industry is required.
• Working knowledge of commercial and clinical manufacturing and quality processes, including U.S. and EU pharmaceutical regulations.
• Extensive experience in a virtual manufacturing environment or relevant industry/profession.
• Ability to develop technical solutions to complex problems and identify and implement methods, techniques, procedures, and evaluation criteria to achieve results.
• Ability to guide successful completion of major programs, projects, and/or functions and interpret, execute, and recommend modifications to companywide policies and/or divisional programs.
• Broad understanding and application of technical principles, theories, concepts, and techniques, with extensive knowledge of related disciplines.
• Strong attention to detail when using a PC and reviewing, editing, or proofreading documents.
• Strong analytical and business communication skills, including excellent verbal, written, and presentation skills.
• Proficiency in Word, Excel, and PowerPoint.

Nice To Haves

• Experience in CMO oversight.
• Small-molecule technical knowledge, oral solid dosage form experience, and biologics knowledge.
• Familiarity with serialization.

Responsibilities

• Develop, establish, and maintain QA programs, policies, and procedures to ensure GMP compliance for commercial and clinical trial materials.
• Perform record review and disposition activities for commercial and clinical trial materials, including comprehensive QA assessments.
• Coordinate investigations with vendors and interdepartmental teams to resolve potential product quality issues.
• Oversee the generation, review, and/or approval of internal and external documents used in GMP activities.
• Support the QA Partner in managing vendors, contract facilities, and joint development collaborators on contracts, validation activities, change management, and other QA issues.
• Support implementation of quality systems, including departmental and corporate procedures, to ensure GMP compliance.
• Understand regulatory agency policies and guidance relevant to QA issues.
• Monitor current and proposed quality and scientific issues and advise the supervisor on events affecting Exelixis.
• Support review of quality review and approval documents, including manufacturing, testing, labeling and packaging batch records, and CMC documents submitted to regulatory agencies.
• Author work instructions and standard operating procedures.
• Drive for results.

Benefits

• 401(k) plan with generous company contributions.
• Group medical coverage.
• Dental coverage.
• Vision coverage.
• Life insurance.
• Disability insurance.
• Flexible spending accounts.
• Eligibility for a discretionary annual bonus program, or a sales-based incentive plan for field sales staff.
• Opportunity to purchase company stock.
• Long-term incentives.
• 15 accrued vacation days in the first year.
• 17 paid holidays, including a company-wide winter shutdown in December.
• Up to 10 sick days throughout the calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager