Software Validation Manager (m/w/d)

We are currently looking for a Software Validation Manager (m/w/d) on behalf of our business partner from the pharmaceutical industry based in Biberach.

Das bieten wir Ihnen

• Attraktives Gehalt und langfristige Jobsicherheit durch Konzernzugehörigkeit
• Bis zu 30 Tage Urlaub pro Jahr
• Zuschuss zur betrieblichen Altersvorsorge nach Probezeitende
• Umfangreiche Sozialleistungen, inklusive Weihnachts- und Urlaubsgeld
• Erstattung von Fahrtkosten
• In der Regel einen unbefristeten Arbeitsvertrag
• Gute Übernahmechancen bei unseren Geschäftspartnern
• Zugeschnittene Weiterbildungsmöglichkeiten und kostenlose Sprachkurse
• Ein großes Angebot an Mitarbeitervergünstigungen

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.

Ihr Profil

• Master’s degree (e.g. MBA, MSc) in a scientific/technical field or completed technical/scientific vocational training, with several years' 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