Associate Director / Director, Supplier Quality and Audits

Role: Director/Associate Director of Supplier Quality and Audits, responsible for developing and maintaining Immunome's GxP Supplier Quality Program. Objectives include ensuring compliance, audit readiness, and effective governance of outsourced GxP activities across CDMOs, CROs, labs, and other partners. Responsibilities encompass supplier qualification, risk assessment, ongoing monitoring, audit planning and execution, CAPA management, and maintaining quality agreements. The role supports inspection readiness and collaborates closely with Quality Operations to oversee outsourced quality activities. Qualifications: Bachelor's in a scientific or technical field; 8+ years in biopharma, with direct experience in third-party GxP oversight, supplier audits, and risk management; familiarity with virtual/outsource manufacturing models preferred. Certifications such as ASQ CQA, RQAP, or ISO auditor credentials are highly desirable. High-Value: Focus on GxP supplier oversight in biopharmaceuticals, supporting quality compliance for manufacturing, testing, and clinical operations within a virtual biotech environment. Work setup involves travel up to 20%, with occasional evening/weekend commitments for audits and inspections.