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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 related packaging services for our clients as a comprehensive service provider. Our workforce consists of approximately 3,000 professionals.
Our extensive network across Europe and the USA provides adaptable and specialized solutions through five core 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 of the CordenPharma Group. Alongside the Executive Leadership Team, CPI encompasses central functions such as Sales & Marketing, Legal, HR, 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 to ensure regulatory inspection readiness and manage inspection processes, including regulatory responses and adherence to action implementations.
- Conduct internal Corporate Audits and utilize successful Customer Audits to enhance quality standards.
- Serve as a Subject Matter Expert, providing guidance to Drug Product sites on GxP compliance and regulatory developments.
- Promote Quality Execution Excellence by integrating risk management and gap assessment principles to ensure facilities, systems, and technologies are fit for purpose.
- Lead initiatives for Global Quality Best Practices, fostering a Quality Culture and supporting cross-functional optimization, harmonization, and transformation projects.
- Drive continuous improvement and enhancement 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 continuously improve 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, with a strong background in Fill & Finish Aseptic manufacturing.
- Significant experience in a GxP controlled environment in a Quality role.
- Fluent in English, with excellent interpersonal and communication skills in interdisciplinary teams.
- Willingness to travel (less than 20%), with internal auditor qualifications.
- Proficient in electronic systems, ideally familiar with Trackwise, LIMS, SAP, eCTD, and EDMS.
- 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 for employee convenience.
- A strong team spirit and positive working culture.
If you are passionate about working in a collaborative environment and are eager to take on a diverse range of responsibilities, we encourage you to consider this role.
