Global TPM/Supplier QA Product Manager

Thornton Tomasetti; Weesp; On-site; EUR 110,000 - 160,000; Full time

Job summary

Abbott is seeking a Third Party Manufacturer and Technical Transfer QA Manager for the Netherlands site in Weesp. You will lead TPM QA management, product transfer, and technical support across TPMs, ensuring cGMP compliance and strong collaboration with cross-functional teams.

The role requires a strong background in GMP/GCP, QA leadership, and change control. Expect up to 30% travel and ongoing quality improvements across the EPD Established Pharma division.

Qualifications

• Bachelor-level degree in science or equivalent.
• Minimum 10 years in pharmaceutical manufacturing (Quality, production, technical support).
• Understanding of Pharmaceutical Manufacturing and Testing Operations.

Responsibilities

• Provide QA support for TPMs to ensure compliant, high-quality products.
• Develop Quality Improvement Plans for TPM remediations.
• Lead TPM activities and continuous improvement initiatives.
• Maintain TPM Approved Supplier Listing and monitor QA performance.
• Coordinate audits, CAPA, change control, & regulatory documentation with TPMs.

Skills

Quality management

Leadership

Communication skills

Strategic planning

GMP/GCP knowledge

Problem solving

Negotiation

Education

Bachelor's degree in science

Tools

Microsoft Office

IRCA Lead Auditor

Auditor Certification

GMP-GDP Training

Job description

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.

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

As Third Party Manufacturer and Technical Transfer QA Manager, you’ll be responsible for TPM QA Management and Product Transfer and Technical Support for assigned TPMs. This position works out of our in Netherland site in the Established Pharmaceutical Division, where 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. As the TPM QA Manager, you’ll be responsible for:

• Providing QA support for assigned TPM’s to ensure that safe, efficacious, and quality product can be supplied to Abbott to meet cGMP and other applicable regulatory standards and the appropriate market requirements.
• Responsible for development of Quality Improvement Plan for TPMs remediations, when required.
• Managing TPM activities while driving continuous improvement for TPMs.
• Responsible for Monitoring quality performance for assigned TPMs and ensure requirements per Quality Technical Agreements are adhered / followed by assigned TPMs
• Leading Quality Technical Agreements approval and periodic review
• Primary contact for communication of TPM Quality issues as needed.
• Responsible for maintaining TPM Approved Supplier Listing.
• Responsible for supporting Quality Compliance and improvement initiatives.
• Support new contract manufacturing site approvals must approve all new contract manufacturers for EPD commercial product within responsibility.
• QA Lead for investigations, trends, complaints, corrective and preventive actions (CAPA), validation support, product release issues, PQR review and change control at TPM sites
• QA lead for co-ordination with TPMs and internal cross functional team as support and interfaces for routine Quality requirements like GMP audits, new projects or initiatives.
• Analyzes data, makes decisions or provides recommendations to senior staff regarding quality related issues & crises.
• Work cross functionally in identifying and resolving technical issues across different EPD regions.
• Recommends and implements changes to the system as the result of changing regulations and/or business needs.
• Coordinates across functional areas, business units, and/or geographies in order to achieve the impact goals.

As Product Technology Transfer QA Manager Act as QA Lead for below quality activities during Product Technology Transfer Leading the initiation and implementation of Change Control / Stability and Change Impact Assessment. Test Method Transfer/Analytical Method Validation/Verification. Process Validation/Verification Program First lot quality review for release the validation batches for commercialization. Gather information from the Sending Unit, in order to assemble a data package. Evaluate the information gathered and document findings with respect to product robustness. Participate to the process of creation, approval and continuous improvement of the regulatory documentation related to EPD products. Provide support for the specification setting to Regulatory Affairs and receiving unit. Provide contributions for the Product technical knowledge during and after technology transfer and ensure the product meeting the Quality Standards. Facilitate issue resolution for key investigation and compliance issues Involve in support the quality aspects of the Product Portfolio Expansion, Geographic Expansion initiatives NPI (New Product Introduction) and other Non-Centrally Supported Products. Ensure that projects and technical activities associated with Drug Substances, Drug Products, Intermediates and non-pharma products (food supplement, medical device, cosmetics) are carried out without business interruptions and according to legal and Abbott Quality, Regulatory and business requirements. Liaison between sites QA, commercial affiliates, MS&T (Manufacturing Science and Technology), Operation, Regulatory and other groups as necessary. Serve as quality technical resource of regional EPD Quality organization during process and regulatory deficiency issues, risk assessment target cost initiatives and other continues improvement initiatives.

Required Qualifications

• Bachelor’s degree in science, pharmacy / pharmaceutical technology, biotechnology / microbiology or equivalent level of education at a relevant scientific discipline.
• Minimum 10 years of experience in the pharmaceutical manufacturing field (Quality, production, technical support, etc.)
• Comprehensive understanding of a wide range of Pharmaceutical Manufacturing and Testing Operations
• Knowledge of international and local quality system and compliance legislations and standards GMP/GLP/GCP background related to medicinal products, medical device, food supplement Biotechnological, Biosimilars and Biologics
• Good communication and report writing skills in English (mandatory).
• Strong leadership skills in bringing the best out of people, managing work teams and fostering teamwork within the department.
• Strong strategic Planning/ Thinking, decisive judgement, and Implementation skills.
• Flexible for Travel: 30 %

Preferred Qualifications

• Highly skilled on cGMP requirements and Quality Assurance / Quality Control manager for solid, liquid, injectable and biosimilar products.
• High capabilities in time management, negotiation skills, multi-tasking, communication skills and Microsoft offices.
• Other qualifications/certifications: IRCA Lead Auditor Certification, Auditor Certification Training, Complaint Certification , GMP-GDP Training.
• Highly skilled on cGMP requirements, team management, and Quality Assurance / Quality Control manager for solid and injectable products.

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: Netherlands > Weesp : WHS 02 ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Not specified

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Keyboard use (greater or equal to 50% of the workday)

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.

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