Global Quality Operations Manufacturing Senior Specialist Leiden • Panda International
Gevraagd
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Fulltime
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Expert
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Engels (taal)
Aanbod
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Loondienst (tijdelijk)
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Global Quality Operations Manufacturing Senior Specialist (Consultant) | Leiden | Hybrid/Onsite
Are you a QA professional passionate about ensuring quality and compliance within advanced therapy manufacturing? Do you enjoy working close to operations while maintaining oversight of GMP standards?
A leading Cell Therapy and ATMP biotech in Leiden is looking for a Global Quality Operations Manufacturing Senior Specialist to strengthen its Quality team for a 6-month consultancy assignment.
Your daily work
As part of the Quality Operations team, you’ll ensure GMP compliance and support key quality processes across manufacturing and supply chain activities. Working closely with internal stakeholders, you’ll help maintain high operational standards while driving continuous improvement.
Your responsibilities will include:
- Reviewing ATMP manufacturing batch records for clinical activities.
- Managing deviations, CAPAs, and change controls.
- Acting as QA representative for Kitting and SAP-related activities.
- Reviewing and approving documentation for Kitting, Supply Chain, and SAP.
- Supporting quality oversight for return shipments, logbooks, and audit trails.
What you bring
- Bachelor’s or Master’s degree in Biology, Biotechnology, Chemistry, or similar.
- 3–5 years of experience in a GMP-regulated manufacturing environment.
- Strong knowledge of cGMP processes; ATMP or Cell Therapy experience is a plus.
- A proactive, precise, and collaborative mindset.
Why this is interesting for you
This project offers the chance to apply your QA expertise within a pioneering Cell Therapy environment. You’ll play a vital role in maintaining compliance, supporting operational excellence, and contributing to life-changing therapies, all within a dynamic and collaborative setting.
Interested?
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