Senior Specialist, Final Release | Senior Specialist Final Release (m/w/d), hybrides Arbeitsmodell

Job Summary

This Senior Specialist role focuses on supporting the Qualified Person (QP) in the procedural and administrative aspects of final release for investigational medicinal products (IMPs) within a globally operating pharmaceutical company. The core responsibilities involve meticulously reviewing IMP release documentation to ensure strict adherence to submitted regulatory documentation (CTAA/Clinical Trial Authorisation Application), current Good Manufacturing Practice (cGMP), and internal quality instructions, thereby supporting subsequent QP certification. A key component of the role is documenting review outcomes and associated KPIs, alongside actively contributing to the continuous improvement and optimization of release processes and systems. Candidates must possess a scientific Master’s degree or equivalent vocational training, coupled with several years of relevant professional experience in areas like pharmaceutical development, manufacturing, or Quality Assurance. Excellent communication skills are vital for effective collaboration with international and local interfaces to resolve complex issues efficiently.