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.
Apply Now
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
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