Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.
We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized, point-of-care CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.
We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The “make-it-happener”.
We are seeking a highly motivated QC Submissions and Compliance Lead to join our Global Quality Control team located in Leiden, The Netherlands. The Global Quality Control team is responsible for both the central site QC activities as well as defining global standards and policies, which involve testing, sample management, method lifecycle, material risk management, product release strategy and subsequent regulatory submission documents for the sections related to product specifications, excipients, analytical and microbiological testing.
In this role, you are responsible for representing Quality Control in CMC discussions and regulatory filings (i.e. IMPDs, INDs) activities for new products, variations and updates. This includes tracking and coordinating regulatory changes, associated change controls, impact assessments and revision of related documentation (i.e. source documentation). The Lead for Global QC Submissions and Compliance should have attention to detail and ability to work in a fast-paced environment. Next to that the role is overseeing compliance enhancement initiatives at the central site as well as close out of QC related Quality Records.
Your role
