Global Quality Operations 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 is committed to excellence, employing approximately 3,000 professionals across our facilities.

We are currently seeking a Global Quality Manager - Aseptic Operations Oversight to join our team.

Location: Frankfurt

Position Type: Full-time, Permanent

Key Responsibilities:

  • Serve as the Global Quality Business Partner for Drug Product Operations, focusing on Aseptic Fill and Finish processes while ensuring compliance with FDA Aseptic Guidance and EU GMP Guidance, Annex I.
  • Oversee drug product sites to ensure readiness for regulatory inspections and manage inspection processes, including regulatory responses and adherence to action implementations.
  • Conduct internal Corporate Audits and leverage successful Customer Audits to maintain high standards.
  • Act as a Subject Matter Expert, providing guidance on GxP compliance and staying abreast of regulatory trends.
  • Promote 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 to foster a Quality Culture and support cross-functional optimization 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 to enhance performance metrics with a focus on supporting quality and regulatory outcomes.

Your Qualifications:

  • University or Master's degree in natural or pharmaceutical sciences, preferably in Pharmacy, Biotechnology, Microbiology, or a related field.
  • Extensive knowledge of FDA and EU guidelines, including Annex I requirements.
  • A minimum of 10 years of relevant experience in the pharmaceutical industry, particularly in Fill & Finish Aseptic manufacturing.
  • Proficient in a GxP controlled environment in a Quality role.
  • Fluent in English, with excellent interpersonal and communication skills.
  • Willingness to travel (< 20%) and possess internal auditor qualifications.
  • Familiarity with electronic systems such as Trackwise, LIMS, SAP, eCTD, and EDMS is advantageous.
  • Highly self-motivated with a proactive approach and a strong sense of ownership.

What We Offer:

  • 30 days of vacation.
  • A dynamic and stimulating work environment.
  • A cafeteria for employee convenience.
  • A strong team spirit and positive working culture.

If you are passionate about quality management and thrive in a collaborative environment, we encourage you to consider this opportunity.

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