GxP Audit and Inspection Coordinator - Contractor (6 months), Remote

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.

We are seeking a detail-oriented and proactive GxP Audit and Inspection Coordinator to join our team for a 6 month period. The ideal candidate will have a strong life sciences background and a proven track record in biotech, pharmaceutical, or Contract Research Organization (CRO) settings. This role involves supporting the audit and inspections department in ensuring compliance with industry standards and regulations from an operational standpoint.

In this role, your principal accountabilities are to:

• Assist the audit and inspections department with logistical coordination, documentation management, and operational activities related to internal and external audits and inspections.
• Ensure that all operational processes are in alignment with Good Practice (GxP) guidelines.
• Collaborate with internal and external stakeholders to resource and schedule audits, track timelines, generate Corrective and Preventive Action (CAPA) Plans and manage follow-up actions to closure.
• · Provide day-to-day support to internal stakeholders, ensuring seamless operations and adherence to audit and CAPA plan timelines.
• Maintain accurate records of all audit and inspection activities and produce reports summarizing audit and inspection findings and operational insights.
• Support the preparation and logistics of regulatory authority inspections, as needed.