Global Quality Operations Manager

vor 3 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 clients as a comprehensive service provider.

Our commitment to excellence drives us to support our extensive network, ensuring the delivery of the highest quality products that ultimately benefit patients.

The role of Global Quality Manager - Aseptic Operations Oversight encompasses the following responsibilities:

  • Serve as the primary Global 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.
  • Oversee drug product facilities to ensure readiness for regulatory inspections and manage inspection processes, including responses to regulatory inquiries and adherence to action plans.
  • Act as a Subject Matter Expert, providing guidance to drug product facilities on GxP compliance and emerging regulatory trends.
  • Champion Quality Execution Excellence by integrating risk management and gap assessment principles to ensure that facilities, systems, and technologies are fit for purpose.
  • Lead initiatives to promote Global Quality Best Practices, fostering a strong Quality Culture and supporting cross-functional optimization, harmonization, and transformation projects.
  • Drive continuous improvement and enhancement of the global Quality Management System.
  • Facilitate Quality ad-hoc boards for escalations to management, ensuring timely and effective communication until resolution.
  • Develop action plans aimed at consistently improving performance metrics, focusing on quality and regulatory outcomes for CordenPharma Drug Product facilities.

Requirements include:

  • Fluency in English.
  • Flexibility and willingness to travel.
  • Proficiency in electronic systems, with familiarity in Trackwise, LIMS, SAP, eCTD, and EDMS being advantageous.
  • 30 days of vacation.
  • A dynamic and stimulating work environment.

For any inquiries regarding the application process or the position, we are here to assist you.

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