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Global Quality Computer Systems Validation Manager (CSV) (m/f/d)
Frankfurt am Main, Plankstadt bei Heidelberg/Mannheim
Aktualität: 29.11.2023


29.11.2023, Corden Pharma International GmbH
Frankfurt am Main, Plankstadt bei Heidelberg/Mannheim
Global Quality Computer Systems Validation Manager (CSV) (m/f/d)
Act as a Subject of Matter Expert on IT Systems Validation and Lifecycle Management across the CordenPharma network for global IT applications to enhance corresponding Quality standards and processes. Participate as global Quality SPOC in IT projects and ensure compliance according to 21CFR Part11, GMP Annex 11 and GAMP 5 respecting Quality Risk Management and Data Integrity standards. Develop design requirements and implement validation and testing strategies in a GxP environment for new electronic business solutions in tight partnership with the global IT department and external service providers. Mentor CP Site Quality teams as Digital Engineering Expert for the locally implemented electronic systems and support cost-efficient solutions. Present the global validation and lifecycle approach to regulatory authorities and external / internal customers during inspections and audits. Master the complexity of supervising cross-functional teams during execution of new and ongoing validation and qualification activities for computerized systems. Drive optimization projects to continuously improve and harmonize compliance workflows for IT processes, collaborating with the sites and providing trainings to them. Execute internal and external audits and take charge for supplier management of IT service providers. Perform benchmark activities and analyze GxP software trends and present conclusions to the leadership team.
Master's degree in IT, Pharmaceuticals, Engineering, Life Sciences or a similar field. Profound knowledge of FDA- / EU-Guidelines, including computer system validation, quality risk management and data integrity. Long-term professional experience in managing and supporting IT applications in a global GxP environment, preferred in a CDMO business, and knowledge of IT infrastructure regulations. Confident handling with electronic systems, ideally to be familiar with Trackwise, Labvantage LIMS, SAP, eCTD Manager, eDMS, MES system. Experience in leading IT projects with interdisciplinary team members. Fluent communication in English. High carefulness and accuracy in the way of working, conscientiousness and detail-orientation, strong ability to systematically gather and analyze data. Excellent interpersonal and communication skills. Highly self-motivated with «Can do» mentality and a strong sense of ownership. Flexibility and willingness to travel (< 10 %).