External Quality Operations Manager
Core
Main quality contact for Contract Manufacturing Organizations (CMOs), overseeing external manufacturing quality and acting as a Qualified Person (QP) delegate for EU batch release.
Role type
Senior Quality Operations Manager (QP Delegate)
Builds
Reliable supply of externally manufactured pharmaceutical products for the EU market
Domain
Pharmaceutical manufacturing / Quality Assurance / GMP
Required skills
GMP/GDP compliance, QP delegate activities, CMO qualification, deviation/CAPA management, risk assessment, audit support, technology transfer
Preferred skills
Global operations, quality KPIs, health authority inspections (FDA/EMA), quality risk management tools
Technologies
EU GMP Annex 16, Sobi procedures
Responsibilities
Lead quality oversight of CMOs ensuring compliance with GMP/GDP; Act as QP delegate for EU batch release; Support CMO qualification and maintain QTAs; Manage deviations, CAPAs, complaints, and change requests; Review product quality and stability reports; Support CMO audits and health authority inspections; Lead quality in technology transfers and product launches
Seniority
Senior, hands-on IC
