Senior GCP/PV/GLP QA Manager

Summary The Senior GCP/GVP QA Manager is accountable for assisting with the development, implementation and maintenance of end‑to‑end QA systems and activities for GCP/GLP operations. Responsibilities include planning and supporting vendor audits, ensuring rapid escalation and issue resolution, and forging strong relationships with partners and collaborations. Responsibilities Assist the development of internal processes and systems related to GCP/GVP QA activities. Provide direct support to development and clinical study teams; participate in QA planning and implementation to support study operations. Develop, track and manage periodic management reports, including key GCP/GVP compliance and QA metrics. Determine approach to complex compliance issues, rapidly escalating findings and ensuring CAPAs are implemented and documented. Support, train internal staff and oversee GCP/GVP consultants as applicable. Implement policies and procedures within GCP/GVP QA. Partner with Regulatory Affairs, Clinical Operations, Translational Medicine, etc., providing compliance guidance and influencing stakeholders. Maintain knowledge of current regulatory requirements and inform Clinical Development stakeholders of potential impacts. Qualifications Education: BS/BA with a minimum of 9 years of related experience; or MS/MA with a minimum of 7 years; or PhD with at least 2 years; or an equivalent combination of education and experience. Experience: Typically 6–8 years of related CQA, GCP, GVP experience, or a combination of experience and education/training. Experience in the biotech or pharmaceutical industry is preferred. Knowledge & Skills: Demonstrated knowledge of drug development processes; GCP/GVP audit conduct and management experience; working knowledge of supporting GCP/GVP preparation and submission activities for global regulatory filings. Excellent verbal, written, and presentation communication skills; ability to translate complex concepts across all levels of the organization. Strong interpersonal and social skills, ability to influence and negotiate feasible solutions, and drive collaborative teamwork. Technical expertise and proven ability to develop solutions to complex problems, interpret policies, and recommend modifications. Detail‑oriented with a commitment to precision and proficiency in MS Office (Word, Excel, PowerPoint). Physical Demands Work is performed in a modern, open‑plan office with ergonomic workstations. On‑site travel may be required (15–20%). Compensation & Benefits The base pay range is $163,000 – $231,000 annually, adjusted for geographic location and experience. Exelixis offers a comprehensive Total Rewards program that includes a 401(k) plan with company contributions, group medical, dental, and vision coverage, life and disability insurance, flexible spending accounts, discretionary annual bonuses (and sales incentives for field sales staff), stock purchase and long‑term incentive plans, 15 accrued vacation days in the first year, 17 paid holidays (including a December shutdown), and up to 10 sick days per year. Equal Opportunity Employment 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, or basis of disability, or any other federal, state or local protected class. #J-18808-Ljbffr