Senior QA Manager, GMP GxP Auditing & Vendor Management

Regulatory Jobs; Redwood City (CA); On-site; USD 164,000 - 205,000; Full time

Job summary

Revolution Medicines in Redwood City is seeking an experienced Lead Auditor to drive GxP compliance and supplier quality programs, conducting internal and external audits and leading corrective action follow-ups across the organization.

The role requires coordinating audit schedules, drafting quality agreements, performing risk assessments, and ensuring GMP/GxP compliance with suppliers. Travel up to 25% and strong leadership skills are essential.

Qualifications

• BA/BS degree in Biological Sciences, Chemistry, or related field.
• Minimum 8+ years pharmaceutical/biotech experience with at least 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.
• Experience with Quality System electronic databases.
• Strong written and oral communication and negotiation skills.
• Ability to travel occasionally (up to 25%).

Responsibilities

• Lead GxP internal audits and external audits including audit reports and corrective actions.
• Maintain internal/external audit schedules and ensure follow-up.
• Assure GMP/GxP compliance with suppliers.
• Oversee vendor/supplier program management for GxP compliance.
• Draft and implement Quality Agreements with vendors and partners.
• Perform risk assessments, qualifications, and monitor suppliers/CMOs.
• Collaborate with cross-functional teams and represent Quality Vendor Management in meetings.
• Develop tools to improve compliance, consistency, and efficiency for GMP/GxP auditing and vendor management.
• Support regulatory inspections and partner audits with cross-functional teams.
• Maintain approved GxP supplier list and annual audit schedules.

Skills

Leadership

Communication

Negotiation

Travel readiness

Education

BA/BS in Biological Sciences, Chemistry, or related field

Tools

Microsoft Office

Quality databases

Job description

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 assessment experience.

• Strategic thinking, and project management skills.

• Extensive experience leading audits, evaluating CAPA and developing presentations analyzing complex data.

#LI-JC1 #LI-Remote

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [e-mail].

Base Pay Salary Range

$164,000—$205,000 USD