Senior Quality Control Manager in GMP Analytics | Senior Quality Control Manager in der GMP-Analytik*

Job Summary

This Senior Quality Control Manager role focuses on ensuring GMP compliance within the analytical quality control department for a biopharmaceutical company specializing in innovative stem cell therapies (ATMPs). The core responsibilities include managing the validation of analytical test procedures, overseeing equipment qualification, and creating/reviewing critical GMP documentation such as SOPs, risk analyses, and specifications. The manager will be responsible for planning and coordinating quality tests, implementing CAPA, handling deviations, Change Control, and OOS procedures, and ensuring the quality control of raw, intermediate, and final products. This position requires a Master's degree in Biosciences, ideally a PhD, and at least five years of relevant experience in a GMP-regulated pharmaceutical environment. The successful candidate must possess strong expertise in flow cytometry, ELISA, and qPCR, coupled with excellent communication skills and the ability to provide technical guidance to junior staff. The role offers the opportunity to contribute to late-stage authorization studies for 21st-century medicine.