Software Validation Manager | Software Validation Manager (m/w/d)
akut... Kompetente Lösungen GmbH
Job Summary
This role is for a Software Validation Manager to lead an international project team focused on validating computer-aided systems within pharmaceutical development. The manager will ensure lean implementation and continuous improvement of CSV&C standards in the NCE department, overseeing the planning, configuration, installation, and testing of systems in compliance with GxP and security requirements. Key responsibilities include managing validation activities for complex international applications, developing new solutions, and collaborating globally on lifecycle documentation. The ideal candidate will possess a Master's degree in a scientific-technical field or relevant professional training with extensive experience in GxP, 21 CFR Part 11, and ISPE GAMP 5 validation standards. This hybrid role offers a responsible position within an innovative pharmaceutical company with opportunities for professional development.
Required Skills
Education
Master's degree (e.g., MBA, MSc) in a scientific-technical field or completed technical/scientific vocational training with several years of professional experience
Experience
- Professional experience with validation requirements for computer-aided systems in a regulated GxP environment
- Experience with 21 CFR Part 11 and ISPE GAMP 5 standards
- Project management experience
- Leadership experience
Languages
Additional
- This is a hybrid work model, allowing 1-2 days per week or as needed from home/remotely. The position is currently limited to 18 months, with an option for extension.
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