Introduction

 

Internal job advertisement 

Department: 

Location: Caponago

 

Global Quality Manager – Aseptic Operations Oversight (m/f/d) 100%
Frankfurt, Germany

  • Caponago
  • ASAP
  • Full-time
  • Permanent

Your Tasks

  • 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

Your Profile

  • 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. 

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