Thermo Fisher Scientific

Quality Engineer III - Product Quality Leader

Thermo Fisher Scientific  •  Groningen, NL (Onsite)  •  5 months ago
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Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

🚀 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.

Thermo Fisher Scientific

About Thermo Fisher Scientific

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

For more information, please visit www.thermofisher.com.

Industry
Biotech & Life Sciences
Company Size
10,000+ employees
Headquarters
Waltham, MA
Year Founded
Unknown
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