Global Quality Assurance Manager

vor 4 Wochen

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

CordenPharma International GmbH is a prominent Contract Development and Manufacturing Organization (CDMO) specializing in the development and production of active pharmaceutical ingredients, medications, and related packaging services. Our organization employs approximately 3,000 professionals across various locations.

We are currently seeking a Global Quality Manager - Aseptic Operations Oversight to join our team. This role is essential for ensuring compliance with regulatory standards and enhancing our quality management systems.

Key Responsibilities:

  • Serve as the Global Quality Business Partner for Drug Product Operations, emphasizing Aseptic Fill and Finish processes.
  • Oversee regulatory inspection readiness and manage inspection processes, including responses and adherence to action plans.
  • Conduct internal corporate audits and facilitate successful customer audits.
  • Provide expert guidance on GxP compliance and regulatory trends to drug product sites.
  • Lead initiatives for Quality Execution Excellence, integrating risk management and gap assessment principles.
  • Drive continuous improvement within the global Quality Management System.
  • Moderate ad-hoc quality boards for escalations to management, ensuring effective communication and timely resolutions.
  • Develop action plans to enhance performance metrics, focusing on quality and regulatory outcomes.

Your Qualifications:

  • Master's degree in natural or pharmaceutical sciences, preferably in Pharmacy, Biotechnology, or Microbiology.
  • Extensive knowledge of FDA and EU guidelines, particularly Annex I requirements.
  • A minimum of 10 years of relevant experience in the pharmaceutical sector, with a strong background in Fill & Finish Aseptic manufacturing.
  • Proficient in English, with excellent communication skills.
  • Willingness to travel occasionally, with internal auditor qualifications preferred.
  • Familiarity with electronic systems such as Trackwise, LIMS, SAP, eCTD, and EDMS.
  • Strong interpersonal skills and a proactive, self-motivated approach.

What We Offer:

  • 30 days of vacation.
  • A dynamic and engaging work environment.
  • A supportive team culture.

If you are passionate about quality management and meet the qualifications outlined above, we encourage you to consider this opportunity.

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