Software Validation Manager, Pharmaceutical Environment | Software Validation Manager (m/w/d) pharmazeutisches Umfeld

Job Summary

This critical role involves leading an international project team responsible for the validation of all computerized systems within pharmaceutical development, ensuring strict adherence to CSV&C (Computerized System Validation & Compliance) standards in the NCE department. The manager will oversee the planning, configuration, installation, and rigorous testing of systems, focusing heavily on GxP and security requirements. Key duties include managing complex international validation activities, developing new solutions, and optimizing existing applications. The role requires strong collaboration with worldwide functions to maintain lifecycle documentation, alongside developing and delivering training and key-user concepts for system adoption. Candidates must bring extensive professional experience with validation standards (GxP, 21 CFR Part 11, ISPE GAMP 5), proven project management and leadership capabilities, and fluent proficiency in both German and English. This position operates within a hybrid work model, requiring onsite presence for onboarding and 1-2 days per week thereafter.