QA Specialist Facilities & Equipment

Job description

Pleased to meet you, we are CellPoint, a Galapagos company. We’re a dynamic fast growing Biotech company, in the business of changing lives.

Galapagos’ mission is to make a lasting positive contribution to society through discovery of innovative therapies for diseases with large unmet medical need. Galapagos seeks to develop a robust portfolio of therapies that have the potential to revolutionize existing treatment paradigms. The company’s ambition is to become a leading global biopharmaceutical company, focused on the discovery, development and commercialization of innovative medicines to improve patients’ lives. Galapagos’ historic focus on developing first-in-class medicines based on the discovery of novel targets in inflammation and fibrosis has led to the successful launch of our first medicine in rheumatoid arthritis in 2020 and in ulcerative colitis in 2021. The pivotal study in Crohn’s Disease is fully recruited and we expect topline data and potential approval in this new indication in a couple of years.

Galapagos is now entering an exciting new chapter to expand and diversify its pipeline for the future, starting with oncology, specifically CAR-T cell-therapy, a transformative treatment of different types of cancer. Through the combined acquisitions of CellPoint and AboundBio, we are propelling ourselves into next-generation cell therapies. CellPoint brings a novel, decentralized point-of-care gene therapy manufacturing model which offers efficient, 7-day time to treatment and avoids complex logistics, resulting in potential better patient outcomes and broader access. CellPoint currently has two products in Phase I/II clinical trials. For more information, please visit

For the CellPoint/Galapagos organisation in Leiden/NL, we are looking for a QA Specialist Facilities & Equipment to join our dynamic environment in setting up, promoting and maintaining QA systems.

Scope of the role:

As CellPoint QA Specialist Facilities & Equipment, you join our Quality Assurance team located in the Leiden Bio Science Park. A fast-growing team building an internal quality system as well as a decentralized QA model working closely together with the point-of-care manufacturing partners. We look forward to welcoming you to co-develop workflows for quality topics, achieving out-of-the-box solutions.

Our goals are ambitious, and we achieve them as a team. This is reflected in how we support each other and in the division of our tasks. Dynamic, fast, and varied describes the workflow you can expect.

The main responsibilities are :

  • Manage QA related topics regarding facilities such as warehouse, laboratories and cleanrooms. This includes management of access control, warehouse procedures and equipment, licensing (GMO, GLP, GCP, GDP, GMP), cleaning, monitoring, etc.
  • Maintain oversight and control of equipment status at CellPoint’s central site as well as at the point-of-care manufacturing partners’ sites.
  • Work in collaboration with Manufacturing and QC teams to manage equipment lifecycle including contract management, equipment qualification, maintenance management and digital management system deployment.
  • Support, maintain oversight and control of computerized systems validations of vendor provided software packages as well as in-house developed software.
  • Support development and implementation of CellPoint’s trainings to enhance GMP awareness in facilities & equipment area.

Job requirements

Who are you?

  • You have a master’s degree in a relevant field
  • Preferably with at least 2 years of experience in a GMP environment resulting in working knowledge of cGMP and regulatory regulations
  • You have hands-on experience in lab activities
  • Proficient in phase appropriate equipment qualification, calibration and maintenance (i.e. clinical vs commercial settings)
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities
  • Result-driven and a pro-active, can-do mindset, without compromising quality and compliance
  • You have a supportive QA mindset
  • You have affinity with digital document management
  • You have good interpersonal skills and written and spoken fluency in English
  • You have an eye for detail and work accurately

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 CellPoint/Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organisational skills. Our employees are the strength behind Galapagos/CellPoint, you will join a highly motivated team, eager to maintain our leading position and to achieve breakthroughs in pharmaceutical research. New team members have the opportunity to actively shape their position and contribute to our mission. Galapagos/CellPoint offers a competitive remuneration package and a dynamic work environment. Flexible working hours can be discussed.

We are Galapagos : together we make it happen…!