GMP Quality Systems Expert

We want to bring cell and gene therapy faster to patients. Do you have a Master in life sciences, passion for research and affinity with quality systems, Good Manufacturing Practice and communication? Then we are looking for you! 😊

Dit ga je doen

You will work in DARE-NL, a national consortium of experts in oncological cell and gene therapy (Advanced Therapy Medicinal Products, ATMPs). DARE-NL comprises a virtual infrastructure for harmonizing ATMP development in the Netherlands, with the aim to make ATMPs better and faster available for cancer patients. All academic institutes that conduct research into ATMPs for cancer patients in the Netherlands are affiliated with DARE-NL. By collaborating with fundamental and translational researchers, GMP experts, technicians and clinicians from different disciplines, new innovative medicines can more quickly be translated into a production process that is suitable for clinical use. You will collaborate with cross-functional teams including research, development and quality assurance.

As a quality expert you are responsible for the quality policy of oncological cell and gene therapy medicinal products. You are responsible for the infrastructure for document, data and knowledge exchange according to FAIR (Findable, Accessible, Interoperable, Reusable) and GDP (Good Distribution Practice) principles. You will provide functional application management of Infoland's Zenya software and participate in subprojects such as writing and reviewing GMP-compliant documents and digitizing batch record software. You will also support the documentation, templates and support QMS implementation for the translation and development of new ATMPs in collaboration with the UMC Utrecht Innovation Center for Advanced Therapies. You will transfer your knowledge, experience and practice to colleagues and identify and communicate areas for improvement.

You will also manage the project website and be involved in educational programs and knowledge exchange platforms. You ensure that the DARE-NL project website remains up-to-date, do the functional management of the Teams/SharePoint environment and take care of project communication together with the project manager. Putting DARE-NL on the map, such as setting up and actively managing a LinkedIn page, is also part of your job description.

Hier ga je werken

You will work in the research group of Dr. Trudy Straetemans within the Kuball Laboratories and together with the Innovation Center of Advanced Therapies (ICAT). A unique concept developed by this group are TEGs: T-cells manipulated with a gamma delta T-cell receptor. These are currently being investigated in a clinical phase I study. The research team with whom you will collaborate coordinates these and other clinical studies.

Dit neem je mee

We are seeking a highly motivated individual to join our versatile, interdisciplinary environment in cell-and gene therapy. In addition you also have:

• A Master of Science in a relevant (bio)medical subject, or a Bachelor of Science combined with relevant working experience.
• Experience with quality management (GMP, FAIR and GDP principles); experience to work with Zenya is a plus.
• Experience/affinity with Information and Communication Technology is a plus.
• Professional proficiency in both Dutch and English (written and spoken).
• Ability to think and work analytically, accurately and project-based.

Wij geloven in de kracht van een divers team waarin ruimte is voor verschillende vaardigheden, expertises, sociale en culturele achtergronden. Wij zijn benieuwd naar jou!