Global Quality Assurance Manager – Aseptic Operations

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, medicinal products, and associated packaging services. With a workforce of approximately 3,000 employees, we are dedicated to delivering comprehensive service solutions.

Our operational network spans Europe and the USA, providing tailored and specialized services across five core technology platforms: peptides, lipids & carbohydrates, injectables, highly potent active ingredients & oncology, and small molecules. We are committed to excellence in supporting this network and ensuring the highest quality products for patient benefit.

Position Overview

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

Key Responsibilities
  • Serve as the Global Quality Business Partner for Drug Product Operations, emphasizing Aseptic Fill and Finish processes and adherence to FDA's Aseptic Guidance and EU's GMP Guidance, Annex I.
  • Oversee drug product sites regarding regulatory inspection readiness and management, including responses to regulatory inquiries and adherence to action implementations.
  • Conduct internal Corporate Audits and leverage successful Customer Audits to enhance compliance.
  • Act as a Subject Matter Expert, providing guidance to Drug Product sites on GxP compliance and emerging 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 Quality Culture and support cross-functional optimization, harmonization, and transformation projects.
  • Drive continuous improvement and enhancement 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.
Candidate Profile
  • 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 a strong background 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.
  • Willingness to travel (< 20%) and possess 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 for employee convenience.
  • A collaborative team spirit and positive working culture.
Further Information

If you are interested in a diverse area of responsibility and possess a proactive mindset, we encourage you to consider this opportunity.

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