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QA PoC Specialist EU/US
For the CellPoint/Galapagos organization in Leiden/NL, we are looking for a QA PoC Specialist EU/US to join us in setting up, promoting and maintaining the QA model for CellPoint’s dynamic business environment.
As CellPoint QA PoC Specialist EU/US, you join our Quality Assurance team located in the Leiden Bio Science Park. We are a small, but fast-growing team, building an internal quality system as well as a decentralized QA model for our expanding organisation. We work closely together with the point-of-care manufacturing units (PMU’s).
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:
• Whilst designing and setting up the quality management system, you co-develop workflows to achieve solutions for point-of-care GMP monitoring.
• Act as CellPoint’s QA single point of contact for a set of point-of-care manufacturing units (PMU’s) creating and maintaining an excellent relationship where quality development is the mutual goal.
• Initial qualification of PMU’s and start up an upward cycle of quality monitoring and development.
• Lead training sessions to educate on quality oversight model and transfer technical knowledge.
• Co-develop a QA KPI monitoring system for PMU’s resulting in oversight and control for CellPoint’s central site.
• You have a relevant master’s degree
• At least 3-5 years of experience in a senior QA role within a GMP environment resulting in working knowledge of QA processes
• Experience in an ATMP environment is a pre
• You are proficient in project management
• You enjoy working in a fast-paced small company environment with minimal direction and are able to adjust workload based on changing priorities
• You are result-driven and adopt a can-do mindset, without compromising quality and compliance
• You have a supportive and constructive QA mindset and a well-developed eye for detail
• You are able to travel for on-site visits to PMU’s for F2F interaction with stakeholders
• You are an independent thinker and resourceful
• You have good interpersonal skills and written and spoken fluency in English
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…!
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 www.cellpoint.bio.