- Lead the QC Lab Operations and QC Support teams, using hands-on expertise to provide guidance on compliance, the different processes and prioritization
- Define and implement the short-term and long-term strategy for the processes related to testing (internal), the maintenance of the laboratories, equipment lifecycle and sample management
- Lead the activities related to GMP readiness of the internal laboratories and processes
- Lead and execute risk assessments, as needed
- Ensure that the processes designed and implemented within the teams are compliant while keeping simple and efficient
- Collaborate cross-functionally to ensure that strategy and processes are aligned and communicated
- Write, review or approve procedures, protocol, and reports
- Support compliance related topics; deviations, CAPAs, change controls, etc.
- Support regulatory filings and health authority questions, including inspections
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Associate Director QC Operations - Leiden, Nederland - Galapagos
Beschrijving
Pleased to meet you, we are CellPoint, a Galapagos company . 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.
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 cell therapy manufacturing model, which has the potential to offer efficient, 7-day time to treatment and avoids complex logistics, resulting in potential better patient outcomes and broader access. For more information, please visit
For the CellPoint/Galapagos organisation in the BioScience Park in Leiden/NL, we are looking for a highly motivated Associate Director to lead the QC Lab Operations and QC Support teams.
Scope
The Associate Director QC Operations would be responsible for leading the QC Lab Operations and QC Support teams while being responsible for providing direction on the strategy and the different processes for which each team is responsible. The QC Lab Operations team amongst other things, is responsible for testing drug product, characterization, product monitoring, immune monitoring and incoming goods samples. The QC Support team is responsible for the lifecycle of equipment, sample management and maintaining the laboratories.
Responsibilities
