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Global Quality Manager
vor 2 Monaten
CordenPharma International GmbH is a leading Contract Development and Manufacturing Organization (CDMO) that develops and produces active pharmaceutical ingredients, medicines, and associated packaging services for its customers. With a network in Europe and the USA, we offer flexible and specialized solutions across five technology platforms.
We are seeking a highly skilled Global Quality Manager - Aseptic Operations Oversight to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our aseptic fill and finish processes.
Main Responsibilities- 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
- 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 familiarity 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
- 30 days of vacation
- Dynamic and exciting work environment
- Cafeteria
- Great team spirit and working culture
If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity. We look forward to receiving your application.
