Global Quality Process Manager

vor 4 Wochen

Frankfurt am Main, Hessen, Deutschland Corden Pharma International GmbH Vollzeit

CordenPharma International GmbH is recognized as a premier Contract Development and Manufacturing Organization (CDMO), specializing in the development and production of active pharmaceutical ingredients, finished medicines, and comprehensive packaging services for our clients. Our workforce comprises approximately 3,000 dedicated professionals.

With a robust network across Europe and the USA, we deliver flexible and specialized solutions through five core technology platforms: peptides, lipids & carbohydrates, injectables, highly potent active ingredients & oncology, and small molecules. Our commitment to excellence ensures that we provide the highest quality products, ultimately benefiting patients worldwide.

Global Quality Process Manager (m/f/d)
  • Location: Frankfurt am Main
  • Employment Type: Full-time, Permanent
Key Responsibilities
  • Act as a Global Quality Business Partner, concentrating on the Quality Management of IT system implementation projects and overseeing the Lifecycle Management of Corporate GxP IT Applications.
  • Serve as a Subject-Matter Expert within the CordenPharma network, ensuring compliance with 21CFR Part 11, GMP Annex 11, and GAMP5 standards.
  • Develop Design Requirements and establish Validation and Testing strategies within a GxP environment for new Electronic Business solutions.
  • Continuously enhance and optimize the Global Validation and Lifecycle approach, presenting it to regulatory authorities and both internal and external customers during inspections and audits.
  • Supervise cross-functional teams within the CordenPharma network during the execution of new and ongoing Validation and Qualification activities for Computerized Systems.
  • Collaborate closely with CordenPharma Site Quality and IT teams to support locally implemented electronic systems and promote cost-effective solutions.
  • Review and implement IT quality-related processes, standards, and systems.
  • Conduct internal and external audits and manage supplier relationships with IT service providers.
Candidate Profile
  • Master's degree in IT, Pharmaceuticals, Engineering, Life Sciences, or a related field.
  • Extensive knowledge of FDA and EU guidelines, particularly in computer system validation, quality risk management, and data integrity.
  • Significant professional experience in Quality Assurance supporting IT applications in a global GxP environment throughout the entire application lifecycle, preferably within a CDMO context.
  • Proficient in managing electronic systems, with familiarity in tools such as Trackwise, Labvantage, SAP, and eCTD Manager.
  • Fluent in English with excellent interpersonal and communication skills.
  • Highly self-motivated, possessing a proactive mindset and a strong sense of ownership.
  • Willingness to travel occasionally.
What We Offer
  • 30 days of vacation annually
  • A dynamic and stimulating work environment
  • Access to a cafeteria
  • An inclusive workplace
  • A positive working atmosphere with an open management culture focused on continuous process improvement and innovation
Interested in Joining Us?

If you thrive in a collaborative team environment and are eager to take on diverse responsibilities while thinking beyond your immediate role, we encourage you to consider joining our team.

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