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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 Assurance Manager – Aseptic Operations
vor 3 Monaten
CordenPharma International GmbH is a prominent Contract Development and Manufacturing Organization (CDMO) specializing in the development and production of active pharmaceutical ingredients, medications, and associated packaging services for its clients as a comprehensive service provider. The organization employs a workforce of approximately 3,000 individuals.
Our extensive network across Europe and the USA provides adaptable and specialized solutions across five key technology platforms: peptides, lipids & carbohydrates, injectables, highly potent active ingredients & oncology, and small molecules. We are dedicated to excellence in supporting this network and are committed to delivering the highest quality products for the benefit of patients.
CordenPharma International (CPI) serves as the management entity for the CordenPharma Group. Alongside the Executive Leadership Team, CPI encompasses central functions such as Sales & Marketing, Legal, Human Resources, and Corporate Development, which operate for the CordenPharma Group on an international scale.
Position: Global Quality Manager – Aseptic Operations Oversight (m/f/d)- Location: Frankfurt
- Employment Type: Full-time
- Contract Type: Permanent
- Act as the Global Quality Business Partner for Drug Product Operations, concentrating on Aseptic Fill and Finish processes while ensuring compliance with FDA's Aseptic Guidance and the EU's GMP Guidance, Annex I.
- Oversee drug product sites regarding regulatory inspection readiness and management, including regulatory responses and adherence to action implementations.
- Conduct internal Corporate Audits and leverage successful Customer Audits.
- Serve as a Subject Matter Expert, providing guidance to Drug Product sites on GxP compliance and regulatory trends.
- Promote Quality Execution Excellence by integrating risk management and gap assessment principles to ensure facilities, systems, and technologies are fit for purpose.
- Lead Global Quality Best Practice initiatives to support Quality Culture and cross-functional optimization, harmonization, and transformation projects.
- Drive continuous improvement and enhancements within the global Quality Management System.
- Facilitate Quality ad-hoc boards for Escalations to Management cases promptly after notification to ensure timely and sustainable actions and effective communication until resolution.
- Develop action plans to continually enhance performance in KPIs, focusing on supporting the quality and regulatory performance of CordenPharma Drug Product sites.
- Master's degree in natural or pharmaceutical sciences, preferably in Pharmacy, Biotechnology, Microbiology, or a comparable qualification.
- Extensive knowledge of FDA and EU Guidelines, including Annex I requirements.
- A minimum of 10 years of relevant experience in the pharmaceutical industry, including:
- In-depth knowledge of Fill & Finish Aseptic manufacturing.
- Significant experience in a GxP controlled environment in a Quality role.
- Fluent in English.
- Willingness to travel (< 20%) and possess internal auditor qualifications.
- Proficient in electronic systems, ideally familiar with Trackwise, LIMS, SAP, eCTD, EDMS.
- Excellent interpersonal and communication skills within interdisciplinary teams.
- Highly self-motivated with a proactive mentality and a strong sense of ownership.
- 30 days of vacation.
- A dynamic and stimulating work environment.
- A cafeteria.
- A strong team spirit and positive working culture.
If you are interested in a diverse area of responsibility and think beyond your immediate tasks, we encourage you to consider this opportunity.
