Third Party Manufacturer and Technical Transfer QA Manager – EMEA

About the role

Abbott's Established Pharmaceuticals Division is hiring a Third Party Manufacturer and Technical Transfer QA Manager for its Istanbul location. The role oversees the quality of third-party manufacturers across the EMEA region and leads quality aspects of product and technology transfers, within a portfolio of branded generic medicines covering gastroenterology, women's health, cardiometabolic, pain management/CNS and respiratory areas.

Key responsibilities

• Oversee quality and performance of third-party manufacturers (TPMs) across EMEA, ensuring compliance with regulations, cGMP, Abbott Quality Standards and Quality Technical Agreements (QTAs)
• Monitor TPM quality performance through metrics, site oversight and risk-based assessments, and act as the main quality contact for TPMs and Global QA
• Lead preparation, approval, implementation, maintenance and renewal of QTAs and maintain the regional Approved Supplier List
• Lead quality system activities: investigations, deviations, change controls, complaints, CAPAs, PQRs, validation, stability programs, trend analysis and product release support
• Provide quality leadership for product transfers, site qualifications, new product introductions, localization projects and lifecycle management
• Review technical and quality documentation, data packages, validation strategies and change impact assessments
• Conduct site visits, audits, performance reviews and remediation programs; analyze quality data and advise senior management
• Collaborate with Regulatory Affairs, Supply Chain, Operations, MS&T, Procurement and Commercial teams

Required profile

• 10+ years of supervisory experience in Quality Assurance, Operations or Pharmaceutical Engineering, including at least 5 years in QA/QC
• Strong knowledge of international and local quality systems, regulatory requirements and cGMP
• Excellent English, including technical report writing; willingness to travel up to 40%
• Professional certifications such as IRCA Lead Auditor, Complaint Handling or GMP/GDP training preferred

Required skills

• Comprehensive understanding of sterile and non-sterile pharmaceutical manufacturing and laboratory testing
• Quality management systems, cGMP and team leadership
• Microsoft Office