Global Quality Assurance Manager

vor 3 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 as a comprehensive service provider.

With a workforce of approximately 3,000 employees, we offer tailored and specialized solutions across five key technology platforms: peptides, lipids & carbohydrates, injectables, highly potent active ingredients & oncology, and small molecules.

Our commitment to excellence drives us to support our network and ensure the delivery of the highest quality products for the benefit of patients.

The management company of the CordenPharma Group, CordenPharma International (CPI), encompasses various central functions, including Sales & Marketing, Legal, HR, and Corporate Development, which operate on an international scale.

We are currently seeking a Global Quality Manager - Aseptic Operations Oversight (m/f/d) to join our team.

Main Responsibilities:
  • Act as the Global Quality Business Partner for Drug Product Operations, emphasizing 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 leverage successful Customer Audits.
  • Serve as a Subject Matter Expert, providing guidance to Drug Product sites on GxP compliance and regulatory trends.
  • Promote Quality Execution Excellence by integrating risk management and gap assessment principles to ensure appropriate facilities, systems, and technologies.
  • Lead Global Quality Best Practice initiatives to foster a Quality Culture and support cross-functional optimization, harmonization, and transformation projects.
  • Drive continuous improvement and enhancements 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 continuously improve performance in KPIs, focusing on supporting the quality and regulatory performance of Drug Product sites.
Your Profile:
  • University/Master's degree in natural or pharmaceutical sciences, preferably in Pharmacy, Biotechnology, Microbiology, or a comparable 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 a strong background in Fill & Finish Aseptic manufacturing.
  • Significant experience in a GxP controlled environment in a Quality role.
  • Fluent in English, with excellent interpersonal and communication skills within interdisciplinary teams.
  • 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.
  • Willingness to travel (< 20%) and possess internal auditor qualifications.
What We Offer:
  • 30 days of vacation.
  • A dynamic and engaging work environment.
  • A cafeteria for employee convenience.
  • A strong team spirit and positive working culture.

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

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