QA Point of Care and Central Site Coordinator - Leiden (NL)
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 job
To support our 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.
- 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
Who are you?
- You have a relevant Master’s degree in Biology / Biotech Sciences / Chemistry
- You have at least 5 years of experience in a role within a GMP environment and have thorough working knowledge of cGMP QA processes
- GMP experience is required, experience in an ATMP and a commercial GMP manufacturing setting is preferred
- You work in a consistent manner with internal and external stakeholders to improve the quality level of the organization
- Enjoy working in a fast-paced small company environment and are able to shift focus when this is required
- Result-driven and have a can-do mindset, without compromising quality and compliance
- Independent thinker and are resourceful
- Good interpersonal skills and written and spoken fluency in English
- As the role is based in Leiden (NL) you need to be living nearby
What’s in it for you?
You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment. Flexible working hours can be discussed.
We are Galapagos: together we make it happen…!