Global TPM/Supplier QA Product Manager

Abbott; Weesp; On-site; EUR 70,000 - 90,000; Full time

Job summary

Abbott is seeking a Third Party Manufacturer and Technical Transfer QA Manager in Weesp, Netherlands. This role requires strong leadership and a minimum of 10 years in pharmaceutical manufacturing.

The successful candidate will ensure quality compliance for third-party manufacturers, manage quality-related initiatives, and lead the approval of Quality Technical Agreements. Excellent communication and strategic planning skills are crucial.

Qualifications

• Minimum 10 years of experience in pharmaceutical manufacturing.
• Comprehensive understanding of quality systems and compliance legislation.
• Strong strategic planning and implementation skills.

Responsibilities

• Provide QA support for assigned TPMs to meet quality standards.
• Manage TPM activities while driving continuous improvement.
• Lead approval and review of Quality Technical Agreements.

Skills

Leadership skills

Communication skills

Knowledge of GMP/GLP/GCP

Strategic planning

Time management

Education

Bachelor’s degree in a relevant scientific discipline

Job description

Third Party Manufacturer and Technical Transfer QA Manager- EMEA

TPM QA Manager Responsibilities

• 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 TPM remedial actions when required.
• Managing TPM activities while driving continuous improvement for TPMs.
• Responsible for monitoring quality performance for assigned TPMs and ensuring requirements per Quality Technical Agreements are adhered to by the TPMs.
• Leading approval and periodic review of Quality Technical Agreements.
• Primary contact for communication of TPM Quality issues as needed.
• Responsible for maintaining the 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 coordination with TPMs and internal cross‑functional teams as support and interfaces for routine Quality requirements such as GMP audits, new projects or initiatives.
• Analyzes data, makes decisions or provides recommendations to senior staff regarding quality related issues and crises; works cross‑functionally in identifying and resolving technical issues across different EPD regions.
• Recommends and implements changes to the system as a result of changing regulations and/or business needs.
• Coordinates across functional areas, business units, and/or geographies in order to achieve impact goals.

Product Technology Transfer QA Manager Responsibilities

• 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 of 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 in the 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 product technical knowledge during and after technology transfer and ensure the product meets the Quality Standards; facilitate issue resolution for key investigation and compliance issues.
• Support 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 supplements, medical devices, cosmetics) are carried out without business interruptions and according to legal and Abbott Quality, Regulatory and business requirements.
• Liasion between sites QA, commercial affiliates, MS&T, Operations, Regulatory and other groups as necessary.
• Serve as a quality technical resource of the regional EPD Quality organization during process and regulatory deficiency issues, risk assessment, target cost initiatives and other continuous improvement initiatives.

Required Qualifications

• Bachelor’s degree in science, pharmacy / pharmaceutical technology, biotechnology / microbiology or equivalent level of education in 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 systems and compliance legislations and standards.
• GMP/GLP/GCP background related to medicinal products, medical devices, food supplements, 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, decisive judgement, and implementation skills.
• Flexible for travel: 30 %

Preferred Qualifications

• Highly skilled on cGMP requirements and Quality Assurance / Quality Control management for solid, liquid, injectable and biosimilar products.
• High capabilities in time management, negotiation skills, multi‑tasking, communication skills and Microsoft Office.
• 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 management for solid and injectable products.

Abbott is an Equal Opportunity Employer, committed to employee diversity.