Group Lead Quality Assurance – GMP 3 | Gruppenleitung (m/w/d) Quality Assurance – GMP 3

Job Summary

This leadership role involves the disciplinary and technical management of the QA GMP 3 team, focusing on aseptic filling and packaging processes within the pharmaceutical sector. The Group Lead is responsible for ensuring strict adherence to internal quality standards and GMP regulations, including US FDA requirements, across all relevant departments and interfaces. Key responsibilities include initiating and implementing measures for process and quality improvement, managing quality systems (Non-Conformities, CAPA, Change Control), and overseeing validation and qualification processes. The ideal candidate possesses a scientific or engineering degree, extensive leadership experience in a GMP environment, and strong knowledge of aseptic manufacturing processes. This position is crucial for maintaining patient safety, preparing for regulatory inspections and customer audits, and contributing to the strategic development of the QA department.