Global Quality Operations Manager

vor 3 Wochen

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

CordenPharma International GmbH is a prominent Contract Development and Manufacturing Organization (CDMO) dedicated to 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 unwavering as we support our extensive network, ensuring the delivery of the highest quality products that ultimately benefit patients.

Position Overview: We are seeking a Global Quality Manager – Aseptic Operations Oversight (m/f/d) to oversee quality assurance for drug product operations, particularly focusing on Aseptic Fill and Finish processes while ensuring compliance with FDA's Aseptic Guidance and the EU's GMP Guidance, Annex I.

Key Responsibilities:

  • Supervise drug product facilities to ensure readiness for regulatory inspections and manage inspection processes, including responses and adherence to action implementations.
  • Serve as a Subject Matter Expert, providing guidance on GxP compliance and regulatory trends to drug product sites.
  • 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 for Global Quality Best Practices, fostering a strong Quality Culture and supporting cross-functional optimization, harmonization, and transformation projects.
  • Drive continuous improvement within 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 enhancing performance in KPIs, focusing on the quality and regulatory performance of drug product sites.

Qualifications:

  • Fluent in English with strong communication skills.
  • Proficient in electronic systems, preferably familiar with Trackwise, LIMS, SAP, eCTD, and EDMS.
  • 30 days of vacation offered.

We offer a dynamic and engaging work environment where your expertise can make a significant impact.

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