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Head of Quality Control Leiden SIRE Life Sciences

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Gevraagd

  • 37 - 40 uur
  • Senior
  • Engels (taal)

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  • Vast contract
 

Vacature in het kort

Leiden
The Company This organization is a global leader in advanced therapeutics, dedicated to transforming lives by discovering better ways to prevent, intercept, treat, and cure diseases. With a focus on innovation and collaboration, the Analytical Development team brings together top scientific minds to drive the future of healthcare forward. Role Description We are seeking an experienced Head of QC to support the Quality Control Development (QCD) labs within the Analytical Development department. In this critical...
 

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SIRE Life Sciences
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The Company
This organization is a global leader in advanced therapeutics, dedicated to transforming lives by discovering better ways to prevent, intercept, treat, and cure diseases. With a focus on innovation and collaboration, the Analytical Development team brings together top scientific minds to drive the future of healthcare forward.

Role Description
We are seeking an experienced Head of QC to support the Quality Control Development (QCD) labs within the Analytical Development department. In this critical role, you will ensure quality compliance, lead operational reviews, and provide guidance on GMP practices across the QC function.

Responsibilities
- Serve as Head of QC, reviewing and approving qualification study plans, equipment validation reports, and related documentation.
- Lead compliance team meetings to monitor progress of nonconformances, change controls, CAPAs, etc., using internal systems (e.g., Comet).
- Advise on phase-appropriate GMP implementation and assist in writing/reviewing SOPs.
- Draft and review nonconformances and actions where needed.
- Act as QC representative in governance and cross-functional meetings.
- Maintain high-quality standards in line with Quality KPIs and compliance benchmarks.

Requirement
- Master’s degree in Life Sciences or equivalent through work experience.
- At least 10 years of experience in the pharmaceutical industry.
- Minimum 5 years in a senior GMP compliance/QC role.
- Strong background in GMP compliance management.
- Hands-on experience with lab systems and quality documentation tools.
- Fluent in English (Dutch is a plus).

Other Information
Intersted? Feel free to click on below link to discuss further.

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