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Quality Engineer III - Product Quality Leader @ Thermo Fisher

Groningen, NLOnsiteFull-time
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About this role

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description

🚀 We’re hiring: Product Quality Leader

📍 Groningen, Netherlands | Biologics | Quality Operations Are you a quality professional who thrives in complex, regulated environments and wants to make a real impact in biopharmaceutical manufacturing? We’re looking for a Product Quality Leader to help ensure the highest standards of quality and compliance for our biologics portfolio. 🔬 Your Impact As Product Quality Leader, you are the quality owner for assigned products and projects, responsible for regulatory compliance and final product disposition to our customers. You’ll work at the heart of a multi-product, multi-client manufacturing site, partnering closely with Project Management, Manufacturing, QC, Engineering, and Regulatory Affairs. 💼 What You’ll Do

• Act as decision-maker for release and disposition of cell banks and bulk drug substance • Serve as a quality and cGMP advisor to project core teams and customers • Review and approve investigations, change controls, and relevant cGMP documentation • Support process, product, and testing validation activities • Lead quality aspects of complaints, recalls, change controls and deviations • Support regulatory inspections and customer audits • Drive continuous improvement of quality systems and ways of working 🎯 What You Bring

• Academic degree in Biotechnology, Biochemistry, Microbiology, Pharmacology, or similar • 5+ years’ experience in a (bio)pharmaceutical GMP environment • Strong knowledge of international cGMP regulations • Experience in project-based or multi-client settings • Confident decision-maker with strong communication and collaboration skills 🌍 Why Join Us

• Work on cutting-edge biologics that make a global impact • Be part of a high-performing, collaborative quality team • Enjoy a role with visibility, ownership, and influence • Grow your career in a dynamic, regulated manufacturing environment 👉 Interested? Apply now or reach out to learn more.

Skills

communication skillsvalidation activitiescollaboration skillsquality systemsbiotechnologycgmp manufacturingpharmaceutical cgmpcontinuous improvementinvestigationschange controlscustomer auditsproject managementregulatory compliancecgmpdecision making

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