Global Quality Manager

Vor 4 Tagen

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

Job Summary:

Corden Pharma International GmbH is seeking a highly skilled Global Quality Manager to oversee Aseptic Operations Oversight. This role will be responsible for ensuring compliance with FDA's Aseptic Guidance and the EU's GMP Guidance, Annex I.

Main Responsibilities:

  • Supervise drug product sites on regulatory inspection readiness and inspection management, including regulatory responses and action implementation adherence.
  • Perform internal Corporate Audits and leverage successful Customer Audits.
  • Act as a Subject Matter Expert to provide guidance to Drug product sites regarding GxP compliance and regulatory trends.
  • Champion Quality Execution Excellence integrating risk management and gap assessment principles ensuring fit for purpose facilities, systems and technologies.
  • Lead Global Quality Best Practice activities supporting Quality Culture and cross-functional optimization, harmonization and transformation projects.
  • Drive continuous improvement and enhancement within the global Quality Management System.
  • Moderate Quality ad-hoc boards for Escalations to Management cases rapidly after notification to ensure timely and sustainable actions and effective communication until resolution.
  • Model action plans to continually improve performance in KPIs with focus on supporting the quality and regulatory performance of CordenPharma Drug Product sites.

Requirements:

  • University / Master degree in natural or pharmaceutical sciences - preferred in Pharmacy, Biotechnology, Microbiology or a comparable qualification.
  • In-depth knowledge of FDA- / EU-Guidelines including Annex I requirements.
  • At least 10 years of relevant work experience in the pharmaceutical industry including:
    • Extensive knowledge of Fill & Finish Aseptic manufacturing.
    • Long-standing experience in a GxP controlled environment in a Quality role.
    • Fluent English language skills.

What We Offer:

  • 30 days of vacation.
  • Dynamic and exciting work environment.
  • Cafeteria.
  • Great team spirit and working culture.

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