Senior QA Manager, GMP GxP Auditing & Vendor Management at REVOLUTION Medicines in Redwood City, California, United States

Responsibilities

• 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.

Requirements

• 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.
• 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.

Skills

Required

• Negotiation skills

Preferred

• Strategic thinking
• Project management skills

Benefits

• 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.
• $164,000 - $205,000 USD