Company
Our client is a globally operating organization in the life sciences sector, focused on delivering high-quality medicines for patients worldwide. The site in the Netherlands plays a key role in labelling, packaging, storage, and distribution for both commercial and clinical supply chains, working in a fast-paced, international environment with high quality and compliance standards.
Job Description
For our client in Breda, we are looking for a Clinical Supply Chain Quality Assurance Specialist to provide QA oversight across the clinical supply chain and support production-related quality activities. The role ensures investigational medicinal products are handled in full compliance with GMP/GDP requirements, supporting smooth release, distribution, and packaging/labelling operations for clinical trials.
Responsibilities
- Provide quality guidance and oversight for investigational medicinal products to ensure GMP/GDP compliance
- Review batch documentation to support batch certification activities
- Review and approve clinical label artwork and support packaging/labelling quality checks
- Assess and document temperature excursions during transport and at clinical sites/depots
- Support investigation and resolution of quality/compliance issues related to manufacturing, packaging, and distribution
- Review and approve minor deviations in line with internal procedures and regulatory expectations
- Draft, update, and maintain operational SOPs and work instructions
- Review SOPs to ensure alignment with corporate standards, site procedures, and regulatory requirements
- Prepare and contribute to monthly quality metrics and reporting
- Work cross-functionally with stakeholders across supply chain, warehouse/distribution, production, - quality, clinical operations, and regulatory teams
- Perform QA-on-the-floor activities such as pack checks, batch record review, and compliance checks - ---during manufacturing activities
Requirements
- Master’s degree (preferably Life Sciences or a related field)
- Several years of experience in Quality Assurance and/or manufacturing within pharma, biotech, or medical devices
- Hands-on experience with documentation review (e.g., batch records) and deviation/investigation support
- Solid knowledge of GMP and GDP (GCP is a plus)
- Strong attention to detail, structured way of working, and a compliance-focused mindset
- Good communication skills and ability to collaborate with multiple stakeholders
- Fluent in English
Other Information
The role is based on-site in Breda and offers the opportunity to work in an international environment supporting clinical trial supply activities end-to-end.
If you are interested and want to apply, please submit your application via the apply button below and contact me.
59254
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