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Thermo Fisher
Thermo Fisher

Leading company in the technology industry

Quality Engineer III - Product Quality Leader

职能QA
级别资深
地点Groningen, Netherlands
方式现场办公
类型全职
发布2个月前
立即申请

必备技能

Quality Assurance

GMP

cGMP

Regulatory Compliance

Project Management

Communication

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.

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关于Thermo Fisher

Thermo Fisher

Thermo Fisher Scientific Inc. is an American life science and clinical research company. It is a global supplier of analytical instruments, clinical development solutions, specialty diagnostics, laboratory, pharmaceutical and biotechnology services.

10,001+

员工数

Waltham

总部位置

$200B

企业估值

评价

10条评价

3.5

10条评价

工作生活平衡

2.8

薪酬

3.2

企业文化

4.1

职业发展

2.9

管理层

2.7

65%

推荐率

优点

Great team culture and dynamics

Excellent benefits and health plans

Supportive management

缺点

Heavy workload and frequent overtime

Poor management and lack of direction

Limited advancement opportunities

薪资范围

2,095个数据点

Junior/L3

Mid/L4

Junior/L3 · DATA ANALYST

1份报告

$130,000

年薪总额

基本工资

$100,000

股票

-

奖金

-

$130,000

$130,000

面试评价

3条评价

难度

3.3

/ 5

时长

14-28周

录用率

33%

体验

正面 0%

中性 67%

负面 33%

面试流程

1

Application Review

2

HR Screen

3

Hiring Manager Interview

4

Panel Interview

5

Offer

常见问题

Behavioral/STAR

Past Experience

Technical Knowledge

Culture Fit