Senior QA Manager, GMP GxP Auditing & Vendor Management

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.

The Opportunity:

- Lead GxP internal audits and external audits including completing audit reports and follow-up on corrective actions.

- Maintain the internal/external audit schedules.

- Assure GMP/GxP compliance with suppliers.

- Oversight of all aspects of GxP vendor / supplier program management to ensure compliance with GxP regulations and RevMed internal standards.

- Demonstrate the ability to multi-tack. Prioritize work and independently solve problems.

- Collaborate with vendors and internal teams to draft and complete Quality Agreements.

- Perform Risk Assessments, qualifications, and monitor Suppliers/CMOs.

- Collaborate with cross-functional teams and represent Quality Vendor Management at meetings.

- Create and implement any tools to improve compliance, consistency, and efficiency for GMP/GXP auditing and Vendor management.

- Provide support preparation of anticipated regulatory inspections (including those at contracted organizations), and partner audits with cross-functional teams.

- Maintain supplier management program, ensuring requirements, plans, processes, metrics, and tracking system for GxP suppliers are established and followed.

- Responsible for qualifications of GMP suppliers including performing audits, generation of audit reports, and follow- up with suppliers for addressing observations from audits.

- Negotiate, draft, and manage quality technical agreements (QTA) and/or contracts with suppliers, ensuring alignment with internal standards, regulations, and industry standards.

- Lead meetings for alignment, communication, and resolution of issues.

- Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to RevMed procedures.

- Lead supplier performance metrics to monitor the health of systems, drive proactive identification of risk, and mitigate compliance issues.

- Generate slides and presentations for reviews and communication to stakeholders.

- Update Veeva, track KPIs, assure GxP audits.

- Maintain the approved GxP supplier list and the annual audit schedules.

Required Skills, Experience and Education:

- BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience and education.

- Minimum experience required 8+ years of pharmaceutical/Biotech experience with a minimum of 5+ years’ GMP Lead Auditor experience.

- 5 years of QTA and Supplier Quality Management experience.

- ASQ Certified Quality Auditor or equivalent certifications.

- Excellent leadership and people management/development skills as required.

- Direct experience working with Quality System electronic databases.

- Strong written and oral communication skills as well as negotiation skills.

- Ability to travel occasionally (up to 25%) to perform external audits.

- Flexible, and an ability to navigate through rapid growth and adapt to rapid change.

- Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word) required.

Preferred Skills:

- Direct experience writing and negotiating Quality Agreements with Suppliers and partners.

- Vendor Qualification and risk ass