Senior QA Manager, GMP GxP Auditing & Vendor Management
Revolution Medicines
Revolution Medicines seeks a Senior QA Manager to lead GMP/GxP auditing and vendor management for an oncology company. The role oversees internal and external audits, supplier compliance, quality agreements, and regulatory inspection preparation across the organization's supply chain.
Responsibilities
- Lead and conduct GxP internal and external audits, including report generation and corrective action follow-up
- Manage audit schedules, supplier qualifications, risk assessments, and monitoring of CMOs and suppliers
- Draft and negotiate quality technical agreements and contracts with suppliers aligned to regulations and standards
- Develop supplier performance metrics and maintain approved supplier lists and compliance tracking
- Support regulatory inspection preparation and lead cross-functional meetings for issue resolution
Requirements
- BA/BS in Biological Sciences, Chemistry, or related field, or equivalent experience
- 8+ years pharmaceutical or biotech industry experience
- 5+ years GMP Lead Auditor experience
- 5 years Quality Technical Agreement and Supplier Quality Management experience
- ASQ Certified Quality Auditor or equivalent certification
- Experience with Quality System electronic databases
- Strong leadership and people management skills
Vacancy posted 11 days ago
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