Third Party Manufacturer and Technical Transfer QA Manager– EMEA

1146 Abt Labs ithalat lhracat Ve Ticaret Ltd; 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

JOB DESCRIPTION: Third Party Manufacturer and Technical Transfer QA Manager– EMEA

About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

The Opportunity This position works at Istanbul location in the Established Pharmaceuticals Division that we are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

What You’ll Do Accountable for the Quality oversight and performance management of Third Party Manufacturers (TPMs) across the EMEA region, ensuring compliance with applicable regulations, cGMP requirements, Abbott Quality Standards, and Quality Technical Agreements (QTAs). Monitor and evaluate TPM quality performance through quality metrics, site oversight activities, and risk-based assessments to ensure the continuous supply of safe, effective, and compliant products. Serve as the primary Quality contact for TPMs, Global QA functions, and internal stakeholders, ensuring effective communication, escalation, and resolution of quality and compliance issues. Lead the preparation, approval, implementation, maintenance, and periodic renewal of Quality Technical Agreements (QTAs), and maintain the regional Approved Supplier List. Lead and support quality system activities including investigations, deviations, change controls, complaints, corrective and preventive actions (CAPAs), Product Quality Reviews (PQRs), validation activities, stability programs, trend analysis, and product release support. Provide Quality leadership and oversight for product transfers, technology transfers, site qualifications, new product introductions, localization projects, and lifecycle management activities to ensure successful commercialization and ongoing compliance. Review and evaluate technical and quality documentation, data packages, validation strategies, change impact assessments, and product robustness assessments to ensure compliance with quality and regulatory requirements. Support the development, review, and continuous improvement of regulatory and quality documentation, specifications, and quality management processes throughout the product lifecycle. Conduct routine TPM and supplier oversight activities, including site visits, audits, performance reviews, remediation programs, and continuous improvement initiatives to strengthen quality systems and compliance. Analyze quality data and trends, assess risks, provide recommendations to senior management, and support the resolution of critical quality, compliance, and business continuity issues. Ensure projects involving pharmaceutical products, medical devices, food supplements, intermediates, and raw materials are executed in compliance with applicable regulations, quality requirements, business needs, and contractual obligations. Collaborate with cross-functional teams including Regulatory Affairs, Supply Chain, Operations, Manufacturing Science & Technology (MS&T), Procurement, and Commercial organizations to achieve quality, compliance, and business objectives. Drive quality compliance and continuous improvement initiatives by implementing quality system enhancements, process optimizations, and regulatory or business-driven changes across the external manufacturing network.

Required Qualifications 10+ years of supervisory experience in Quality Assurance, Operations, or Pharmaceutical Engineering, including a minimum of 5 years of experience in Quality Assurance and/or Quality Control functions. Comprehensive understanding of sterile and non-sterile pharmaceutical manufacturing and laboratory testing operations. Strong knowledge of international and local quality systems, regulatory requirements, compliance standards, and industry best practices. Extensive experience with cGMP requirements, quality management systems, team leadership, and Quality Assurance/Quality Control management for sterile and non-sterile pharmaceutical products. Excellent time management, negotiation, multitasking, communication, and Microsoft Office skills. Strong leadership capabilities with a proven ability to develop teams, drive performance, and foster a collaborative work environment. Excellent written and verbal communication skills in English, including technical report writing. Willingness and ability to travel up to 40% of the time. Professional certifications and training preferred, including IRCA Lead Auditor Certification, Auditor Training, Complaint Handling Certification, and GMP/GDP Training.

The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Quality Assurance DIVISION: EPD Established Pharma LOCATION: Türkiye > Istanbul : Saray Mah Dr Adnan Buyukdeniz Cd Umraniye ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.