Global Quality Manager Operations

Vor 5 Tagen


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

Job Summary:

Corden Pharma International GmbH is seeking a highly skilled Global Quality Manager Operations to join our team. As a key member of our organization, you will be responsible for ensuring the highest quality standards in our operations.

Key Responsibilities:

  • Supervise drug product sites on regulatory inspection readiness and inspection management, including regulatory responses and action implementation adherence.
  • 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.
  • Model action plans to continually improve performance in KPIs with focus on supporting the quality and regulatory performance of CordenPharma Drug Product sites.

Requirements:

  • Fluent English language skills.
  • Flexibility and willingness to travel.
  • Confident handling in electronic systems, ideally familiarity with Trackwise, LIMS, SAP, eCTD, EDMS.

What We Offer:

  • 30 days of vacation.
  • Dynamic and exciting work environment.


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