Global Quality Manager

Vor 2 Tagen

Frankfurt am Main, Hessen, Deutschland Corden Pharma International GmbH Vollzeit
Global Quality Manager - Aseptic Operations Oversight

CordenPharma International GmbH is a leading Contract Development and Manufacturing Organization (CDMO) that develops and produces active pharmaceutical ingredients, medicines, and associated packaging services for its customers. Our network in Europe and the USA offers flexible and specialized solutions across five technology platforms: peptides, lipids & carbohydrates, injectables, highly potent active ingredients & oncology, and small molecules.

We are seeking a highly skilled Global Quality Manager - Aseptic Operations Oversight to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and regulatory compliance of our aseptic fill and finish processes.

Main Responsibilities
  • Supervise drug product sites on regulatory inspection readiness and inspection management, including regulatory responses and action implementation adherence
  • Perform internal Corporate Audits and leverage successful Customer Audits
  • Act as a Subject Matter Expert to provide guidance to Drug product sites regarding GxP compliance and regulatory trends
  • Champion Quality Execution Excellence integrating risk management and gap assessment principles ensuring fit for purpose facilities, systems, and technologies
  • Lead Global Quality Best Practice activities supporting Quality Culture and cross-functional optimization, harmonization, and transformation projects
  • Drive continuous improvement and enhancement within the global Quality Management System
  • Moderate Quality ad-hoc boards for Escalations to Management cases rapidly after notification to ensure timely and sustainable actions and effective communication until resolution
  • Model action plans to continually improve performance in KPIs with focus on supporting the quality and regulatory performance of CordenPharma Drug Product sites
Requirements
  • University / Master degree in natural or pharmaceutical sciences - preferred in Pharmacy, Biotechnology, Microbiology, or a comparable qualification
  • In-depth knowledge of FDA- / EU-Guidelines including Annex I requirements
  • At least 10 years of relevant work experience in the pharmaceutical industry including:
  • Extensive knowledge of Fill & Finish Aseptic manufacturing
  • Long-standing experience in a GxP controlled environment in a Quality role
  • Fluent English language skills
  • Flexibility and willingness to travel (< 20%), Internal auditor qualification
  • Confident handling in electronic systems, ideally familiarity with Trackwise, LIMS, SAP, eCTD, EDMS
  • Excellent interpersonal and communication skills within interdisciplinary teams
  • Highly self-motivated with 'Can do' mentality and a strong sense of ownership
What We Offer
  • 30 days of vacation
  • Dynamic and exciting work environment
  • Cafeteria
  • Great team spirit and working culture

If you are a motivated and experienced professional looking for a new challenge, please submit your application. We look forward to hearing from you.

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