Global Quality Operations Manager

vor 3 Wochen

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

CordenPharma International GmbH is a prominent Contract Development and Manufacturing Organization (CDMO) specializing in the development and production of active pharmaceutical ingredients, finished pharmaceuticals, and related packaging services.

We are dedicated to excellence in our operations and are committed to delivering the highest quality products for the benefit of patients worldwide.

Role Summary

The Global Quality Manager for Aseptic Operations Oversight will serve as a key partner in ensuring compliance with regulatory standards and quality assurance for Drug Product Operations, particularly focusing on Aseptic Fill and Finish processes.

Key Responsibilities
  • Oversee drug product facilities to ensure readiness for regulatory inspections and manage inspection processes, including responses and adherence to action plans.
  • Act as a Subject Matter Expert, providing guidance on GxP compliance and current regulatory trends to drug product sites.
  • Promote Quality Execution Excellence by integrating risk management and gap assessment principles to ensure that facilities, systems, and technologies are fit for purpose.
  • Lead initiatives for Global Quality Best Practices, fostering a culture of quality and supporting cross-functional optimization and transformation projects.
  • Drive continuous improvement efforts within the global Quality Management System.
  • Facilitate Quality ad-hoc boards for escalations to management, ensuring timely communication and sustainable actions until resolution.
  • Develop action plans aimed at enhancing performance metrics with a focus on quality and regulatory compliance across CordenPharma Drug Product sites.
Qualifications

Fluency in English is required, along with proficiency in electronic systems such as Trackwise, LIMS, SAP, eCTD, and EDMS.

We offer a dynamic and stimulating work environment with 30 days of vacation.

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