[Hiring] Senior QA Manager, GMP GxP Auditing & Vendor Management @Revolution Medicines

Role Description

As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

• 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-task, 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.

Qualifications

• 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.

Benefits

• Competitive cash compensation.
• Robust equity awards.
• Strong benefits.
• Significant learning and development opportunities.

Base Pay Salary Range

$150,000 — $189,000 USD