Global TPM & Supplier QA Leader - Product Transfer

Abbott; Weesp; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Abbott in the Netherlands is seeking a Third Party Manufacturer and Technical Transfer QA Manager-EMEA to oversee TPM QA management and product transfer for assigned TPMs. The role covers cGMP compliance, regulatory alignment, and continuous quality improvements within Abbott’s Established Pharma division at the Weesp site.

Responsibilities include leading QA activities for TPMs, coordinating with cross-functional teams, and ensuring product quality across multiple therapeutic areas.

Qualifikationen

• Bachelor’s degree in science, pharmacy/pharmaceutical technology, biotechnology/microbiology or equivalent in a scientific discipline.
• Minimum 10 years in pharmaceutical manufacturing (Quality, production, technical support).
• Comprehensive understanding of Pharmaceutical Manufacturing and Testing Operations.
• Knowledge of international and local quality systems and compliance regulations.
• GMP/GLP/GCP background for medicinal products, medical devices, and related fields.
• Strong English communication and report writing skills (mandatory).
• Strong leadership, team management, and strategic thinking skills.
• Willingness to travel up to 30%.

Aufgaben

• Provide QA support for assigned TPMs to ensure safe, efficacious and quality products meeting regulatory standards.
• Develop Quality Improvement Plans for TPM remediations.
• Manage TPM activities and drive continuous improvement.
• Monitor TPM quality performance and ensure adherence to Quality Technical Agreements.
• Lead approval and periodic review of Quality Technical Agreements.
• Serve as primary contact for TPM quality issues.
• Maintain TPM Approved Supplier Listing.
• Support Quality Compliance and improvement initiatives.
• Assist with new contract manufacturing site approvals for EPD products.
• Lead QA activities during Product Technology Transfer (Change Control, Stability, Method Transfer).
• Coordinate with TPMs and cross-functional teams for GMP audits and initiatives.
• Analyze data and provide senior staff with recommendations on quality issues and crises.
• Coordinate across functions to achieve impact goals.

Kenntnisse

Quality Assurance

QA Leadership

Regulatory Knowledge

GMP/GLP/GCP

English Communication

Travel Willingness

Ausbildung

Bachelor's degree in science

Tools

IRCA Lead Auditor Certification

Auditor Certification Training

Complaint Certification

GMP-GDP Training

Jobbeschreibung

Abbott in the Netherlands is seeking a Third Party Manufacturer and Technical Transfer QA Manager-EMEA to oversee TPM QA management and product transfer for assigned TPMs. The role covers cGMP compliance, regulatory alignment, and continuous quality improvements within Abbott’s Established Pharma division at the Weesp site.

Responsibilities include leading QA activities for TPMs, coordinating with cross-functional teams, and ensuring product quality across multiple therapeutic areas.