Quality Manager Operations

vor 4 Wochen

Frankfurt am Main, Deutschland Corden Pharma International GmbH Vollzeit

CordenPharma is one of the leading Contract Development and Manufacturing Organizations (CDMO) and develops and produces active pharmaceutical ingredients, medicines and associated packaging services on behalf of its customers as a “full-service” service provider. We strive for excellence in supporting this network and are committed to providing the highest quality products for the benefit of patients.
CordenPharma International (CPI) acts as the management company of the CordenPharma Group. In addition to the Executive Leadership Team, CPI has central functions such as Sales & Marketing, Legal, HR and Corporate Development, which work for the CordenPharma Group across locations and at an international level.
Global Quality Manager – Aseptic Operations Oversight (m/f/d) 100 %
Full-time
Permanent
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
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
Moderate Quality ad-hoc boards for Escalations to Management cases rapidly after notification to ensure timely and sustainable actions and effective communication until resolution
Model action plans to continually improve performance in KPIs with focus on supporting the quality and regulatory performance of CordenPharma Drug Product sites
Fluent English language skills
Confident handling in electronic systems, ideally familiarness with Trackwise, LIMS, SAP, eCTD, EDMS
30 days of vacation
~ Dynamic and exciting work environment
~ In case of questions to your application, the position or something else I am very happy to support you.
Otto-Hahn-Strasse | 68723 Plankstadt

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