Third Party Manufacturer and Technical Transfer QA Manager– EMEA
Core
Oversees quality and performance of third-party manufacturers (TPMs) across EMEA, ensuring compliance with cGMP and Abbott standards while leading technical transfers and product lifecycle activities.
Role type
Senior QA Manager (Third Party Manufacturing & Technical Transfer)
Builds
Safe, compliant pharmaceutical products for global markets
Domain
Pharmaceuticals (Sterile & Non-Sterile)
Required skills
cGMP compliance, Quality Technical Agreements (QTAs), supplier oversight, risk-based assessments, CAPA management, product transfer leadership, regulatory documentation review, cross-functional collaboration
Preferred skills
IRCA Lead Auditor Certification, GMP/GDP training, complaint handling certification
Technologies
Microsoft Office
Responsibilities
Monitor TPM quality performance via metrics and site oversight; lead preparation and renewal of Quality Technical Agreements; support product transfers and technology transfers; conduct routine audits and remediation programs; analyze quality trends and assess risks; collaborate with Regulatory, Supply Chain, and Manufacturing teams.
Seniority
Senior, hands-on IC with supervisory experience