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, finished medications, and comprehensive packaging solutions for our clients.

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

Position Overview:

As the Global Quality Manager for Aseptic Operations, you will play a pivotal role in overseeing the quality assurance processes associated with the Aseptic Fill and Finish operations. Your responsibilities will include:

  • Acting as the primary Global Quality Business Partner for Drug Product Operations, ensuring compliance with FDA's Aseptic Guidance and the EU's GMP Guidance, Annex I.
  • Supervising drug product facilities to maintain regulatory inspection readiness and manage inspection processes, including regulatory responses and adherence to action implementations.
  • Providing expert guidance to drug product sites on GxP compliance and staying abreast of 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 within the global Quality Management System.
  • Moderating Quality ad-hoc boards for escalations to management, ensuring timely and effective communication until resolution.
  • Developing action plans to enhance performance metrics with a focus on supporting the quality and regulatory performance of drug product sites.

Qualifications:

  • Fluency in English is required.
  • Proficient in electronic systems, with familiarity in Trackwise, LIMS, SAP, eCTD, and EDMS being advantageous.
  • 30 days of vacation are provided.
  • Experience in a dynamic and stimulating work environment is essential.

We are committed to supporting you throughout your application process and are here to assist with any inquiries regarding the position.

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