Corden Pharma International GmbH

Global Quality Business Partner for Drug Product Operations focused on the Aseptic Fill and Finish processes and compliance with FDA's Aseptic Guidance and the EU's GMP Guidance, Annex I Supervise drug product sites on regulatory inspection readiness and inspection management, including regulatory responses and action implementation adherence Perform internal Corporate Audits and leverage successful Customer Audits Act as a Subject Matter Expert to provide guidance to Drug product sites regarding GxP compliance and regulatory trends Champion Quality Execution Excellence integrating risk management and gap assessment principles ensuring fit for purpose facilities, systems and technologies Lead Global Quality Best Practice activities supporting Quality Culture and cross-functional optimization, harmonization and transformation projects Drive continuous improvement and enhancement within the global Quality Management System Moderate Quality ad-hoc boards for Escalations to Management cases rapidly after notification to ensure timely and sustainable actions and effective communication until resolution Model action plans to continually improve performance in KPIs with focus on supporting the quality and regulatory performance of CordenPharma Drug Product sites