Introduction

Vos tâches

• 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
• Perform internal Corporate Audits and leverage successful Customer Audits
• 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

Votre profil

• University / Master degree in natural or pharmaceutical sciences - preferred in Pharmacy, Biotechnology, Microbiology or a comparable qualification
• In depth-knowledge of FDA- / EU-Guidelines including Annex I requirements
• At least 10 years of relevant work experience in the pharmaceutical industry including:
• extensive knowledge of Fill & Finish Aseptic manufacturing
• Long-standing experience in a GxP controlled environment in a Quality role
• Fluent English language skills
• Flexibility and willingness to travel (< 20%), Internal auditor qualification
• Confident handling in electronic systems, ideally familiarness with Trackwise, LIMS, SAP, eCTD, EDMS
• Excellent interpersonal and communication skills within interdisciplinary teams
• highly self-motivated with “Can do” mentality and a strong sense of ownership.

Please note that this role can be filled at any of Corden Pharma's European sites.