Third Party Manufacturer QA Sr.Associate (TPM QA )

1146 Abt Labs ithalat lhracat Ve Ticaret Ltd; Fatih; On-site; TRY 350,000 - 550,000; Full time

Job summary

Abbott in Istanbul is seeking a TPM QA Sr. Associate to oversee quality for third party manufacturers and ensure cGMP compliance. You will manage investigations, deviations, CAPAs and product release support, with cross‑functional collaboration across QA, Regulatory, Manufacturing and Supply Chain.

The role requires strong analytical skills, English proficiency, and up to 40% travel domestically and internationally. Location: Istanbul, Türkiye.

Qualifications

• Bachelor’s degree in pharmacy, chemistry, chemical engineering, or related scientific discipline.
• 5–7 years of QA, QC, and/or pharmaceutical manufacturing experience in a GMP-regulated environment.
• Good knowledge of cGxP, ICH guidelines, and applicable regulations for pharma products and materials.
• Understanding of manufacturing processes, labs, quality systems, and validation activities.
• Willingness to travel domestically and internationally up to 40%.

Responsibilities

• Ensure quality and compliance performance of assigned TPMs, adhering to cGMP and QTAs.
• Lead investigations, deviations, CAPAs, PQRs, validations, and product release support.
• Review TPM documentation: MBRs, packaging records, validation and stability reports.
• Drive quality oversight via audits, supplier qualification, and cross‑functional projects.
• Coordinate with Supply Chain, Regulatory, Operations, and other stakeholders.

Skills

Analytical skills

Communication skills

English proficiency

Microsoft Office

Education

Bachelor’s degree in pharmacy, chemistry, chemical engineering, or related science

Tools

Microsoft Office

Job description

Job Description: Third Party Manufacturer QA Sr.Associate (TPM QA)

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 and compliance performance of assigned Third Party Manufacturers (TPMs), ensuring compliance with applicable regulations, cGMP requirements, Abbott Global/Regional Policies, and Quality Technical Agreements (QTAs). Responsible for quality risk management activities including deviations, investigations, change controls, CAPAs, product complaints, Product Quality Reviews (PQRs), stability programs, validation activities, and product release support. Review and approve TPMs quality documentation including Batch Manufacturing Records, Packaging Records, Validation Protocols and Reports, Stability Protocols and Reports, PQRs, change controls, deviations, investigations, exceptions, and CAPAs. Lead quality oversight of TPMs through performance monitoring, quality metrics review, GEMBA visits, remediation plans, and continuous improvement initiatives. Serve as the primary Quality contact for assigned TPMs, maintaining effective communication and strong working relationships with internal and external stakeholders. Lead and coordinate quality activities related to GMP audits, supplier qualification, regulatory inspections, technology transfers, new product introductions, and cross-functional projects. Drive investigation, resolution, and escalation of quality and compliance issues, providing risk-based recommendations and support to internal stakeholders and senior management. Manage the preparation, approval, maintenance, and periodic renewal of Quality Technical Agreements (QTAs) and support the maintenance of the Approved Supplier List. Support Regional and Global Quality Compliance initiatives and contribute to the enhancement of quality systems, processes, and regulatory compliance across the external manufacturing network. Coordinate cross-functional teams and collaborate with Supply Chain, Regulatory Affairs, Operations, Procurement, Manufacturing, and other stakeholders to achieve business and quality objectives.

Required Qualifications

• Bachelor’s degree in pharmacy, Chemistry, Chemical Engineering, or a related scientific discipline.
• Minimum 5-7 years of experience in Quality Assurance (QA), Quality Control (QC), and/or pharmaceutical manufacturing within a GMP-regulated environment.
• Good knowledge of cGxP requirements, ICH guidelines, and applicable national and international regulations related to pharmaceutical products, raw materials, medical devices, food supplements, biologics, and biosimilars.
• Sound understanding of pharmaceutical manufacturing processes, laboratory testing operations, quality systems, and validation/qualification activities, including Process Validation, Cleaning Validation, and Equipment Qualification.
• Strong analytical, problem-solving, organizational, and follow-up skills, with the ability to manage multiple priorities and support the resolution of quality and compliance issues.
• Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams and external partners.
• Proficiency in written and spoken English, including technical documentation and report writing.
• Proficiency in Microsoft Office applications.
• Willingness and flexibility to travel domestically and internationally up to 40 % of the time.

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

JOB FAMILY: Operations Quality

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.