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QA Associate for Document Management

Posted 23 Mar 2024
Work experience
0 to 7 years
Full-time / part-time
Full-time
Job function
Degree level
Required language
English (Fluent)

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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 www.cellpoint.bio.

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

Scope of the role:

As CellPoint QA Associate for Document Management, 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 of the QA Associate for Document Management are :

  • As single point of contact for document management in the digital quality management system, you keep oversight and control. This includes quality documents status management, supporting authors and reviewers where needed and maintenance of the digital database.
  • You maintain oversight and control over trainings and qualification status of CellPoint’s central site personnel. You support the team to meet the timelines.
  • You support content and timeline management of deviations, change controls, CAPAs and Audits (internal and external).

Who are you?

  • You have a master’s or bachelor’s degree in a relevant field
  • A first experience in a GMP environment resulting in working knowledge of cGMP and regulatory regulations is a plus, ambitious freshly graduated profiles are also encouraged to apply
  • You are comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities
  • Result-driven and can-do mindset, without compromising quality and compliance
  • You have a supportive QA mindset
  • You are keen to be at the forefront of digital document management knowledge
  • 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…!

Galapagos is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Galapagos’ pipeline comprises Phase 3 through to discovery programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications.

Healthcare
Leiden
1,000 employees