Technical Support GMP Specialist - Contractor (6 months), Leiden

Pleased to meet you, we are Galapagos, a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life.

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 CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.

Scope of the role:

We are seeking a GMP Specialist consultant to join the EU Technical Support team, supporting the GMP activities around equipment and systems available at our decentralized sites . The GMP Specialist will be an ambassador for the overall GMP culture and is a hands-on subject matter expert in handling deviations, CAPAs and Continuous Improvement projects.

Your role:

• Actively engage in fostering understanding to continuously improve the GMP awareness related to the Technical Support area and broader EU Technical Operations team.
• Mentor colleagues in handling deviations and CAPAs.
• Track the progress on deviations and CAPAs and document review/approval.
• Keep oversight on the training assignments within the department.
• Support root-cause investigations for deviations, determine corrective actions and support implementation of change controls.
• Support and foster a culture of Continuous Improvement.
• Closely collaborate with Quality Assurance and other departments.

The GMP Specialist consultant reports to the Head of EU Technical Support.