Global Quality Operations Manager
vor 3 Wochen
CordenPharma International GmbH is recognized as a premier Contract Development and Manufacturing Organization (CDMO), specializing in the development and production of active pharmaceutical ingredients, medications, and related packaging services for our clients as a comprehensive service provider.
Our commitment to excellence drives us to support our extensive network and deliver the highest quality products for the benefit of patients worldwide.
The Global Quality Manager - Aseptic Operations Oversight role encompasses the following responsibilities:
- Act as the primary Global Quality Business Partner for Drug Product Operations, emphasizing Aseptic Fill and Finish processes while ensuring compliance with FDA Aseptic Guidance and EU GMP Guidance, Annex I.
- Oversee drug product facilities to ensure readiness for regulatory inspections and manage inspection processes, including responses to regulatory inquiries and adherence to action plans.
- Serve as a Subject Matter Expert, providing guidance to drug product sites on GxP compliance and current regulatory trends.
- Promote Quality Execution Excellence by integrating risk management and gap assessment principles to ensure facilities, systems, and technologies are fit for purpose.
- Lead initiatives for Global Quality Best Practices, fostering a strong Quality Culture and supporting cross-functional optimization, harmonization, and transformation projects.
- Drive continuous improvement and enhancements 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 aimed at improving performance metrics, focusing on quality and regulatory outcomes of CordenPharma Drug Product sites.
Requirements for this position include:
- Fluency in English.
- Flexibility and willingness to travel.
- Proficiency in electronic systems, with familiarity in Trackwise, LIMS, SAP, eCTD, and EDMS being advantageous.
- 30 days of vacation.
- A dynamic and stimulating work environment.
For any inquiries regarding this position or the application process, we are here to assist you.
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