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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, finished pharmaceuticals, and related packaging services for our clients as a comprehensive service provider.
Our commitment to excellence drives us to support this extensive network, ensuring the delivery of the highest quality products that ultimately benefit patients.
The role of Global Quality Manager - Aseptic Operations Oversight encompasses:
- Acting as the primary Quality Business Partner for Drug Product Operations, with a focus on Aseptic Fill and Finish processes, ensuring compliance with FDA Aseptic Guidance and EU GMP Guidance, Annex I.
- Overseeing drug product sites to ensure readiness for regulatory inspections and managing inspection processes, including regulatory responses and adherence to action implementations.
- Serving as a Subject Matter Expert, providing guidance to drug product sites on GxP compliance and emerging regulatory trends.
- Championing Quality Execution Excellence by integrating risk management and gap assessment principles to ensure that facilities, systems, and technologies are fit for purpose.
- Leading initiatives for Global Quality Best Practices to foster a robust Quality Culture and support cross-functional optimization, harmonization, and transformation projects.
- Driving continuous improvement and enhancement of the global Quality Management System.
- Moderating Quality ad-hoc boards for escalations to management, ensuring timely and effective communication until resolution.
- Modeling action plans to consistently improve performance in KPIs, focusing on supporting the quality and regulatory performance of CordenPharma Drug Product sites.
Key qualifications include:
- Fluency in English.
- Flexibility and willingness to travel.
- Proficiency in electronic systems, with familiarity in Trackwise, LIMS, SAP, eCTD, and EDMS being advantageous.
We offer 30 days of vacation and a dynamic, engaging work environment.
For any inquiries regarding the application or position, we are here to assist you.
