Senior QA Manager, GMP GxP Auditing & Vendor Management

Role: Lead GxP vendor and supplier quality management for a late-stage oncology biopharma developing RAS pathway inhibitors. Responsibilities: conduct internal and external GMP/GxP audits, maintain audit schedules, ensure compliance with regulations, draft and negotiate Quality Technical Agreements, perform risk assessments, monitor supplier qualifications, and lead audit-related inspections. Collaborate with cross-functional teams and external vendors to uphold quality standards, improve compliance processes, and support supplier performance metrics. Prepare audit reports, manage supplier qualification processes, and track KPIs. Requirements: BA/BS in Biological Sciences, Chemistry or related field; 8+ years in pharma/biotech, including 5+ years as GMP Lead Auditor; extensive experience with QTA and supplier quality management; ASQ Certified Quality Auditor or equivalent; strong communication, leadership, and negotiation skills; ability to travel up to 25%. Preferred: experience drafting Quality Agreements, vendor qualification, risk assessment, and audit analysis. High-Value: GxP compliance, GMP audits, supplier qualification, risk management, in a biologics or small molecule context, supporting regulatory inspections and supplier oversight.