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 experienced Global Quality Manager to oversee Aseptic Operations and ensure compliance with regulatory guidelines. The ideal candidate will have a strong background in quality assurance, aseptic manufacturing, and GxP compliance.

Key Responsibilities

  • Supervise drug product sites on regulatory inspection readiness and inspection management
  • Perform internal corporate audits and leverage successful customer audits
  • Act as a subject matter expert to provide guidance on GxP compliance and regulatory trends
  • Champion quality execution excellence, integrating risk management and gap assessment principles
  • Lead global quality best practice activities, supporting quality culture and cross-functional optimization
  • Drive continuous improvement and enhancement within the global quality management system
  • Model action plans to continually improve performance in KPIs

Requirements

  • University/Master degree in natural or pharmaceutical sciences
  • In-depth knowledge of FDA/EU guidelines, including Annex I requirements
  • At least 10 years of relevant work experience in the pharmaceutical industry
  • 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

  • Dynamic and exciting work environment
  • Cafeteria
  • Great team spirit and working culture

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