Ihre Aufgaben:
* As Software Validation Manager, you lead an international project team and you are responsible for the validation of all computerized systems within Pharmaceutical Development to ensure a lean implementation and continuous improvement of CSV&C standards in the NCE division
* With your expertise, you ensure planning, configuration, installation and testing of systems considering GxP and safety requirements
* You are responsible for managing the validation activities for complex international and interdisciplinary applications. Furthermore, you will create new solutions or further develop or optimize existing applications
* Also, you cooperate with worldwide functions who are involved in the generation and maintenance of life cycle documentation
* In addition, you also create and maintain training and key user concepts and organize training for users of validated systems
Ihre Qualifikationen:
* Master’s degree (e.g. MBA, MSc) in a scientific/technical field or completed technical/scientific vocational training, with professional experience
* Professional experience in validation requirements for computerized systems in the regulated environment of GxP, 21 CFR Part 11 and ISPE GAMP 5
* Good understanding of the SOPs/processes landscape of the related business area
* Project management skills and Leadership experience
* Good understanding of development data and data processing requirements as well as Business management mindset
* Good ability to work under pressure, proven communication capabilities in interdisciplinary and international cooperation and strong presentation skills
* Fluent in English and preferably in German
Ihre Vorteile:
* Varied activities in a renowned company
* Support in the ongoing project by our team