Senior QA & GxP Compliance Leader — Supplier Audits

Revolution Medicines, Inc.; San Francisco (CA); On-site; USD 164,000 - 205,000; Full time

Job summary

Revolution Medicines, Inc. is seeking a seasoned Lead Auditor to own GxP audits and vendor qualification, ensuring GMP/GxP compliance across suppliers and CMOs. You will partner with cross-functional teams to drive CAPA closure and improve audit processes.

The role requires 8+ years in pharma/biotech with 5+ years GMP Lead Auditor experience, plus ASQ certification. Occasional travel and strong negotiation skills are essential.

Qualifications

• BA/BS in Biological Sciences, Chemistry, or related field or equivalent experience.
• 8+ years in pharma/biotech with 5+ years GMP Lead Auditor experience.
• 5 years of QTA and Supplier Quality Management experience.
• ASQ Certified Quality Auditor or equivalent certification.
• Strong leadership and people management skills; excellent written and oral communication.

Responsibilities

• Lead GxP internal and external audits, including audit reports and corrective actions.
• Maintain internal/external audit schedules and ensure timely follow-up.
• Oversee GMP/GxP compliance with suppliers and vendor programs.
• Draft and manage Quality Technical Agreements and supplier contracts.
• Collaborate with cross-functional teams and present audit results to stakeholders.
• Support regulatory inspections preparation and partner audits with teams.
• Maintain supplier management programs, KPIs, and audit tracking.
• Generate slides/presentations for governance reviews and communications.

Skills

GxP auditing

Leadership

Vendor management

Communication

Microsoft Office

QA systems

Education

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

ASQ Certified Quality Auditor

Tools

Veeva

QTA tools

Microsoft Office

Job description

Revolution Medicines, Inc. is seeking a seasoned Lead Auditor to own GxP audits and vendor qualification, ensuring GMP/GxP compliance across suppliers and CMOs. You will partner with cross-functional teams to drive CAPA closure and improve audit processes.

The role requires 8+ years in pharma/biotech with 5+ years GMP Lead Auditor experience, plus ASQ certification. Occasional travel and strong negotiation skills are essential.