EMEA TPM QA & Tech Transfer Lead | 40% Travel

Abbott; Fatih; Presencial; TRY 900.000 - 1.500.000; Jornada completa

Descripción de la vacante

Abbott in Istanbul seeks a senior QA Manager to oversee Third Party Manufacturers across the EMEA region, ensuring cGMP compliance and Abbott quality standards. The role drives QTAs, supplier oversight, and continuous improvement within a complex regulatory landscape.

The candidate will lead quality system activities, investigations, CAPAs, and product transfers while collaborating with Regulatory, Supply Chain, and Manufacturing teams for compliant product launches and lifecycle management.

Formación

• 10+ years of supervisory experience in QA/Operations or pharmaceutical engineering.
• 5+ years in QA/QC functions and sterile/non-sterile manufacturing.
• Strong knowledge of international/local quality systems and cGMP requirements.
• Excellent written and verbal English communication and report writing.
• Willingness to travel up to 40% of the time.

Responsabilidades

• Oversee quality assurance for Third Party Manufacturers across the EMEA region to ensure compliance with cGMP and Abbott standards.
• Lead QTAs creation, approval, and renewal; maintain regional Approved Supplier List.
• Drive quality system activities including investigations, deviations, CAPAs, PQRs, and validation.
• Support product transfers, site qualifications, new product introductions, and lifecycle management.
• Collaborate with Regulatory Affairs, Supply Chain, Operations and MS&T to achieve quality goals.

Conocimientos

Quality Assurance leadership

Regulatory compliance

cGMP knowledge

Project leadership

English proficiency

MS Office

Herramientas

Microsoft Office

Descripción del empleo

Abbott in Istanbul seeks a senior QA Manager to oversee Third Party Manufacturers across the EMEA region, ensuring cGMP compliance and Abbott quality standards. The role drives QTAs, supplier oversight, and continuous improvement within a complex regulatory landscape.

The candidate will lead quality system activities, investigations, CAPAs, and product transfers while collaborating with Regulatory, Supply Chain, and Manufacturing teams for compliant product launches and lifecycle management.