GMP Assurance Manager | GMP Assurance Manager (m/w/d)

Job Summary

This critical role involves managing and maintaining robust Quality Assurance (QA) systems within operational departments, specifically manufacturing and testing, to ensure strict compliance with Good Manufacturing Practice (GMP) standards. The manager will oversee key quality processes, including Non-Conformities, Corrective and Preventive Actions (CAPA), Change Control, Qualification, and Validation, while also reviewing and approving essential GMP documentation. Daily tasks include conducting risk assessments, initiating and implementing process improvements, and supporting both regulatory inspections and customer audits. A core focus is optimizing quality systems to achieve and sustain FDA compliance. The ideal candidate must possess a relevant degree in a scientific or engineering field, coupled with extensive pharmaceutical GMP experience, strong cGMP knowledge, and proven skills in project management and regulatory interaction. This position offers the opportunity to contribute to a global specialist in immunology and hematology with a mission to save lives.