Quality Systems Supervisor

Job description

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. Key Responsibilities: - Coordinate the Quality System Compliance team and its related activities - Manage the Self-Inspection process - Manage the GMP documentation on the digital electronic system TrackWise - Oversee the periodic monitoring and analysis of quality KPIs - Manage the CAPA Management process - Manage the alignment of internal procedures with corporate policies. - Manage the risk management process and the risk register - Manage the GMP paper documentations archive and their sending to customers - Act as a subject matter expert during inspections by regulatory agencies, corporate teams, and clients and support in their preparing. Qualifications & Experience: Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language...