Senior QA Leader - GxP & Supplier Audits (Remote)

revolutionmedicines; Redwood City (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Revolution Medicines is seeking a GxP Lead Auditor to lead internal and external audits, ensuring GMP/GxP compliance with suppliers and managing vendor programs. The role requires strong leadership and the ability to draft quality agreements and audit reports.

The position is onsite at our Redwood City, CA headquarters, with occasional travel up to 25%. A background of 8+ years in pharma/biotech and ASQ CQA certification are preferred, along with proficiency in Microsoft Office.

Qualifications

• BA/BS in Biological Sciences, Chemistry, or related field, and/or equivalent experience.
• Minimum 8+ years of 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 skills; ability to travel up to 25%.

Responsibilities

• Lead GxP internal and external audits and draft audit reports.
• Maintain internal/external audit schedules and ensure corrective actions.
• Assure GMP/GxP compliance with suppliers and vendor program management.
• Draft and finalize Quality Technical Agreements with suppliers.
• Prepare for regulatory inspections and support lead audits with cross-functional teams.

Skills

GxP auditing

Quality leadership

Documentation and reporting

Negotiation

Travel readiness

Education

BA/BS in Biological Sciences or related field

Tools

Veeva

Microsoft Office

Job description

Revolution Medicines is seeking a GxP Lead Auditor to lead internal and external audits, ensuring GMP/GxP compliance with suppliers and managing vendor programs. The role requires strong leadership and the ability to draft quality agreements and audit reports.

The position is onsite at our Redwood City, CA headquarters, with occasional travel up to 25%. A background of 8+ years in pharma/biotech and ASQ CQA certification are preferred, along with proficiency in Microsoft Office.