Global Quality Operations Manager

vor 4 Wochen

Frankfurt am Main, Hessen, Deutschland Corden Pharma International GmbH Vollzeit

CordenPharma International GmbH is recognized as a premier Contract Development and Manufacturing Organization (CDMO), specializing in the development and production of active pharmaceutical ingredients, medications, and related packaging services for our clients as a comprehensive service provider.

Our commitment to excellence is reflected in our dedication to delivering the highest quality products, ultimately benefiting patients worldwide.

As the Global Quality Manager – Aseptic Operations Oversight, you will serve as the principal Quality Business Partner for Drug Product Operations, concentrating on Aseptic Fill and Finish processes while ensuring compliance with FDA's Aseptic Guidance and the EU's GMP Guidance, Annex I.

Your responsibilities will include:

  • Overseeing drug product sites to ensure readiness for regulatory inspections and managing inspection processes, including responses and adherence to action implementations.
  • Acting as a Subject Matter Expert, providing guidance to drug product sites on GxP compliance and emerging regulatory trends.
  • Championing Quality Execution Excellence by integrating risk management and gap assessment principles to ensure that facilities, systems, and technologies are fit for purpose.
  • Leading initiatives for Global Quality Best Practices to foster a strong Quality Culture and support cross-functional optimization, harmonization, and transformation projects.
  • Driving continuous improvement and enhancement within the global Quality Management System.
  • Moderating Quality ad-hoc boards for escalations to management, ensuring timely and sustainable actions and effective communication until resolution.
  • Modeling action plans to consistently improve performance in KPIs, focusing on supporting the quality and regulatory performance of CordenPharma Drug Product sites.

Fluency in English is required, along with proficiency in electronic systems, ideally with familiarity in Trackwise, LIMS, SAP, eCTD, and EDMS.

We offer a dynamic and stimulating work environment with 30 days of vacation.

If you have any inquiries regarding your application or the position, we are here to assist you.

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