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QA PoC Manager, Leiden, NL
Shared Services - Quality & Compliance
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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 (PoC) 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 PoC Manager to join us in setting up, promoting and maintaining the QA model for CellPoint’s dynamic business environment.
Scope of the role:
As CellPoint QA PoC manager, you join our Quality Assurance team located in Leiden. We are a small, but fast-growing team, building a QA model for our expanding organisation, working closely together with the point-of-care manufacturing partners.
At CellPoint/Galapagos, we strongly believe in the power of collaboration to achieve ambitious goals. This is reflected in how we divide tasks and support each other. Our workflow is dynamic, fast and varied.
The main responsibilities are:
- Point-of-Care manufacturing site qualification and onboarding
- Point-of-Care manufacturing quality auditing and monitoring
- Point-of-Care Compliance development to enhance consistency
- Performance oversight for point-of-care manufacturing partners by development of PoC quality oversight system applying the digital tools available, including
- Setting up the quality management system for point-of-care manufacturing monitoring in alignment with EU and US regulatory guidelines, working together with the US team.
- Build and develop a team of QA POC Specialists that are responsible for monitoring a set of PoC sites each.
- Maintain product quality oversight, creating consistency using CellPoint’s central site capabilities and data.
The QA PoC manager reports to the QA Director at CellPoint based in the central EU site.
- You have a relevant master’s degree
- With at least 5 years of experience in a senior role within a GMP environment with thorough working knowledge of cGMP QA processes.
- Experience in a ATMP manufacturing setting is preferred
- Experience in a commercial GMP manufacturing setting is preferred
- You are proficient in project management
- You are able to travel for on-site visits to PoC sites for F2F interaction with stakeholders
- You enjoy working 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 are an independent thinker and resourceful
- You have good interpersonal skills and written and spoken fluency in English
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…!