QA Point of Care and Central Site Coordinator

4 weken geleden

Leiden, Nederland Galapagos Voltijd

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.

We’re in the business of changing lives. In our quest to discover and develop life-improving medicines, we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happener’.

For our Cell & Gene Therapy organization in Leiden/NL, we are seeking a highly motivated QA PoC and Central Site Coordinator (Sr. Specialist).

Scope of the role: 

To supportour QA team in setting up, promoting and maintaining the QA model in our dynamic business environment. Our QA team is a team of 11 and plays a crucial role in building our QA model for our expanding organization while working closely together with the Point-of-Care manufacturing partners.

At Galapagos, we strongly believe in the power of collaboration to achieve our ambitious goals. This is reflected in how we divide tasks and support each other. Our workflow is dynamic, fast and varied.

As our QA PoC and Central Site coordinator, you will report to the QA Manufacturing Operations Lead, in the IMP QA Oncology team based in our Central EU site in Leiden, NL.

Responsibilities:

Manage QM attributes for PoC and Central Site activities: Deviations, CAPAs, Change Controls and Complaints QA batch record review Support materials release and support batch release process Support equipment management at our PoC locations Provide QA support to the materials kitting process

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