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GMP Specialist

LocationLeiden, Netherlands
Business SectorBiotechnology
Contact nameCaitlin Girdwood
Contact email
Job ref25610
Published3 days ago

We are seeking an experienced GMP Specialist to join the Quality department for a 6-month full-time contractor role, based in the Leiden area (minimum 3 days/week onsite). This position focuses on deviation and change control, providing oversight, support, and compliance enforcement across cross-functional teams including QA, QC, Manufacturing, Planning, and Supply Chain.

You’ll act as the operational interface between QA and the business, handling major quality events, leading process improvements, and supporting teams with GMP best practices. This is a hands-on, high-impact role ideal for someone with a strong QA background and a deep understanding of GMP in daily operations.

 

Essential Requirements:

  • 7+ years of experience in GMP-regulated operations, ideally in QA or cross-functional roles within pharma or biotech

  • Strong knowledge of deviation management, CAPAs, and change control processes

  • Operational understanding of raw material handling, particularly materials/kits from third-party manufacturers (e.g., Lonza)

  • Experience acting as a liaison between departments (QA, QC, Planning, Manufacturing, MSAT)

  • Confidence to challenge or push back on management/QA where appropriate

  • Experience writing and owning SOPs, work instructions, and GMP documentation

  • Excellent problem-solving, communication, and mediation skills

  • Bachelor’s degree in pharmacy, chemistry, engineering, or a related field


Desirable Requirements:

  • Background in Supply Chain roles alongside QA experience

  • Familiarity with Good Distribution Practices (GDP)

  • Prior use of SAP and/or Quality Management Systems (QMS)

  • Experience managing cross-functional deviation training or effectiveness checks

  • Understanding of raw material flow to Decentralized Manufacturing Units (DMUs)


Additional Insights:

  • Start Date: ASAP

  • Duration: 6-month contract

  • Employment Type: Full-time Consultant

  • Location: Onsite in Leiden, Netherlands (minimum 3 days/week presence required)

  • Interview Process: 1 - 2 rounds with quick turnaround