Global Quality Manager

vor 3 Wochen

Frankfurt am Main, Hessen, 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. The group employs around 3,000 people.

Our network in Europe and the USA offers flexible and specialized solutions across five technology platforms: peptides, lipids & carbohydrates, injectables, highly potent active ingredients & oncology and small molecules. 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.

We are looking for one as soon as possible

Global Quality Manager – Aseptic Operations Oversight (m/f/d) 100 %
  • Frankfurt
  • ASAP
  • Full-time
  • Permanent
Main activities and responsibilities
  • 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
What we offer
  • 30 days of vacation
  • Dynamic and exciting work environment
  • Cafeteria
  • Great team spirit and working culture
Interested?

If you enjoy working in a team and are interested in a varied area of responsibility, if you think and act beyond your own areaof responsibility, then you should join our team.

Do you require more information?
In case of questions to your application, the position or something else I am very happy to support you.

Your contact person

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