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 computerized systems within pharmaceutical development. The manager will ensure lean implementation and continuous improvement of CSV&C standards, overseeing the planning, configuration, installation, and testing of systems while adhering to 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 have a Master's degree in a scientific or technical field or relevant professional experience, strong project management and leadership skills, and expertise in GxP, 21 CFR Part 11, and ISPE GAMP 5 standards. This hybrid position offers a chance to work in an innovative pharmaceutical company with opportunities for professional development.
Required Skills
Education
Master's degree (e.g., MBA, MSc) in a scientific or technical field OR completed technical/scientific vocational training with several years of professional experience
Experience
- Professional experience with validation requirements for computerized systems in a regulated GxP environment
- Leadership experience
- Experience in international and interdisciplinary collaboration
Languages
Additional
- Hybrid work model (1-2 days/week remote); Initial 18-month fixed-term contract with option for extension
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