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Frankfurt am Main, Hessen, Deutschland Corden Pharma International GmbH Vollzeit{"h2": "Global Quality Manager – Aseptic Operations Oversight", "ul": [{"li": "Global Quality Business Partner for Drug Product Operations focused on the Aseptic Fill and Finish processes and compliance with FDA's Aseptic Guidance and the EU's GMP Guidance, Annex I"}, {"li": "Supervise drug product sites on regulatory inspection readiness and inspection...
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Global Quality Operations Manager
vor 3 Monaten
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 associated 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, ultimately benefiting patients worldwide.
The Global Quality Manager - Aseptic Operations Oversight will serve as a pivotal business partner for Drug Product Operations, concentrating on Aseptic Fill and Finish processes while ensuring compliance with FDA's Aseptic Guidance and the EU's GMP Guidance, Annex I.
- Oversee drug product facilities regarding regulatory inspection preparedness and management, including responses to regulatory inquiries and adherence to action implementations.
- Act as a Subject Matter Expert, offering guidance to drug product sites on GxP compliance and emerging regulatory trends.
- Champion 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 robust Quality Culture and driving cross-functional optimization, harmonization, and transformation projects.
- Promote continuous improvement and enhancement 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 the quality and regulatory outcomes of CordenPharma Drug Product sites.
Required qualifications include fluent English language skills, flexibility, and a willingness to travel. Proficiency in electronic systems, particularly Trackwise, LIMS, SAP, eCTD, and EDMS, is preferred.
We offer a dynamic and stimulating work environment, along with 30 days of vacation.
For any inquiries regarding your application or the position, we are here to assist you.
