Associate Director Global Quality Operations

Role: Associate Director, Quality Operations, overseeing external manufacturing quality for Abivax's clinical and future commercial products. Responsibilities: lead QA oversight of contract manufacturing organizations (CMOs), ensure compliant batch disposition, review manufacturing and QC records, and support GMP systems development. Manage and mentor Quality Operations team, facilitate deviations, CAPAs, change controls, and ensure regulatory inspections readiness. Requirements: Bachelor's or Master's in life sciences or equivalent; 8+ years industry experience, preferably with early clinical to commercial phases, small molecule experience preferred. Technical skills include extensive cGMP/ICH/FDA/EMA knowledge, CMO management, and regulatory interaction experience, with familiarity using Veeva. HighValue: experience in facility startup, product disposition, and defending QA processes during inspections. Collaboration with cross-functional teams, regulators, and external partners essential. WorkSetup: not specified; likely corporate office or laboratory environment.