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Leiden.
Ervaren Projectleider Bouw
Den Haag (+16km)
• Prefound
37 - 40 uur
HBO
Medior+
€ 4.500 - € 6.000 p/m
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Compliance Lead Leiden • SIRE Life Sciences
Gevraagd
-
37 - 40 uur
-
Senior
Aanbod
-
Vast contract
Vacature in het kort
Leiden
Join a global pharmaceutical company specializing in biologics, vaccines, and medical devices. The Advanced Therapeutics, Analytical Development team needs a new colleague for a 6-month project within the Quality Control Development group. Your role will involve leading the Compliance Focus team, ensuring quality standards, and supporting quality activities like sample management and equipment qualification. Be part of a team committed to eliminating disease and improving lives through pioneering science. See how you can contribute to our success by reading further.
Over het bedrijf
SIRE Life Sciences
Volledige vacaturetekst
The Company
The company is a part of a global pharmaceutical company manufacturing biologics, vaccines, medical devices and personal care product.
Role Description
We are driven by a vision to eliminate disease and improve lives through pioneering science. Our Advanced Therapeutics, Analytical Development team, is seeking a new colleague for a 6-month assignment. This role is based within the Quality Control Development (QCD) group and plays a vital part in ensuring compliance and quality standards in our laboratory and production environments.
Responsibilities
- Overseeing and approving qualification plans, validation reports, and related documentation.
- Leading the Compliance Focus team, monitoring progress on nonconformances, corrective actions, change controls, and related quality systems in Comet.
- Providing guidance on GMP compliance strategies that align with the developmental phase of products.
- Drafting and reviewing procedures and documentation to support quality initiatives.
- Contributing to nonconformance investigations and corrective actions as required.
- Representing the QCD group in key governance meetings (e.g., GGB).
- Maintaining high-quality standards and ensuring adherence to internal Quality KPIs.
- Supporting various quality activities such as sample and material management, environmental monitoring, equipment qualification, and stability testing coordination.
- Master’s degree in life sciences or equivalent practical experience.
- At least 10 years of experience in the pharmaceutical industry.
- Minimum of 5 years working in a senior GMP-regulated environment.
- Strong background in GMP compliance and quality control management.
- Familiarity with laboratory information and management systems.
- Excellent communication skills in English (and preferably Dutch), both verbal and written.
- Proven interpersonal skills with the ability to build effective cross-functional relationships.
- Detail-oriented, flexible, and proactive with a hands-on, solution-driven attitude.
Other information
Apply to our vacancy for more information. Looking forward to getting in touch!
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