Operations QA Manager - Commercial
About The Position
The Operations QA Manager - Commercial is responsible for quality assurance oversight of end-to-end, day-to-day GMP operations at the 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 for GMP compliance of commercial and clinical trial materials. It performs record review and disposition, coordinates investigations, oversees GMP documentation, and supports vendor and contract-facility quality management. The role also supports quality-system implementation, monitors relevant regulatory and scientific developments, contributes to quality reviews and regulatory submissions, and authors work instructions and standard operating procedures. This role has no supervisory responsibilities and is onsite in Alameda, California, with travel as required.
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 PhD 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.
- Working knowledge of commercial and clinical manufacturing and quality processes, including US and EU regulations affecting the pharmaceutical industry.
- 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 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, as well as knowledge of related disciplines.
- Attention to detail when using a PC, reviewing documents, and editing or proofreading documents.
- Strong analytical and business communication skills, including excellent verbal, written, and presentation communication skills.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Ability to travel as required.
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 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 relevant events for Exelixis.
- Support review and approval of quality 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.
- Provide QA oversight of day-to-day GMP operations at CMOs and assess vendor processes, systems, and procedures against quality standards and regulatory requirements.
- Review batch records and collaborate with partners to identify, mitigate, and escalate product risks.
Benefits
- 401(k) plan with generous company contributions
- Medical, dental, and vision coverage
- Life and 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
