Manager QA GMP (m/f/d)

Job description

Be part of our team We are a dedicated QA team supporting Tubulis development of antibody-drug conjugates (ADCs) and clinical trials with a strong focus on reliable processes and patient safety. Working closely together, we ensure that quality and compliance are part of every step, from research to clinical application. Our team values open communication, practical problem-solving, and a shared responsibility for doing things right. If you enjoy working in a supportive environment where your contributions make a real difference, we’d be happy to hear from you. Your mission: - Review and QA approval of QA related documents and relevant CMC documents - Review of Batch Documentation (e.g. Master Batch Records, executed Batch Records) of Intermediates (Linker Payload, mAb), Bulk Drug Substance, Bulk Drug Product, Finished Product as applicable. - QA-Approval and follow-up Quality events from GMP relevant vendors (Deviations, OOX, Complaints, Quality Issues, CAPAs, Change Control). - QA release of Intermediates and Sponsor release of Investigational Medicinal Product (e.g. for USA) - Lead compilation of Product Specification Files in collaboration with the respective stakeholders as app...