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 for clients as a comprehensive service provider. With a workforce of approximately 3,000 employees, we are dedicated to excellence in our operations.

Our extensive network across Europe and the USA offers tailored and specialized solutions across five key technology platforms: peptides, lipids & carbohydrates, injectables, highly potent active ingredients & oncology, and small molecules. We are committed to delivering the highest quality products to enhance patient outcomes.

Position Overview: We are seeking a qualified individual for the role of Global Quality Manager - Aseptic Operations Oversight (m/f/d) to join our team.

Location: Frankfurt

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's Aseptic Guidance and EU's GMP Guidance, Annex I.
  • Oversee drug product sites to ensure regulatory inspection readiness and manage inspection processes, including regulatory responses and adherence to action implementations.
  • Conduct internal Corporate Audits and facilitate successful Customer Audits.
  • Act as a Subject Matter Expert, providing guidance to Drug Product sites on GxP compliance and regulatory trends.
  • Champion Quality Execution Excellence by integrating risk management and gap assessment principles to ensure facilities, systems, and technologies are fit for purpose.
  • Lead Global Quality Best Practice initiatives to foster a strong Quality Culture and support cross-functional optimization, harmonization, and transformation projects.
  • Drive continuous improvement and enhancements within the global Quality Management System.
  • Moderate Quality ad-hoc boards for escalations to management, ensuring timely and effective communication until resolution.
  • Develop action plans to continuously improve performance metrics with a focus on supporting the quality and regulatory performance of Drug Product sites.

Your Qualifications:

  • University/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, with significant expertise in Fill & Finish Aseptic manufacturing.
  • Proven experience in a GxP controlled environment in a Quality role.
  • Fluent in English, with excellent interpersonal and communication skills within interdisciplinary teams.
  • Flexibility and willingness to travel (< 20%), along with internal auditor qualifications.
  • Proficient in electronic systems, ideally familiar with Trackwise, LIMS, SAP, eCTD, and EDMS.
  • Highly self-motivated with a proactive mindset and a strong sense of ownership.

What We Offer:

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

If you are interested in a diverse area of responsibility and possess the ability to think and act beyond your immediate role, we encourage you to consider this opportunity.

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