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You manage the Quality of Contract Manufacturing Organization and act as Qualified Person for assigned marketed products.
As Qualified Person You are responsible for batch release and batch certification for marketed product. You prepare, host and lead Health Authority Inspections, management of deviations / investigations / complaints / changes and CAPAs review and approval. Furthermore you are in charge of compliance of the marketed products in your area of responsibility toward National and International laws and guidelines such as EMA, FDA and other Health authorities’ regulations as required.
As CMO Quality Manager you act as a single point of contact (internal and external) for all quality related topics associated with you the assigned CMOs. You support Merck outsourcing strategy and insure that compliance and quality standards of the division are met. As member of cross-functional teams, you develop and monitor defined Quality KPIs of assigned CMOs and help the CMOs develop and meet Merck standards. Quality oversight of process and analytical technology transfers to CMOs is in your area of responsibility. You develop and control the implementation of quality/contract related processes and documents together with any internal and external party involved in manufacture and distribution operations.
Who you are:
- Qualified Person for marketed products
- Degree in Pharmacy, Biology or Chemistry
- Project management skills is preferred
- Minimum of 7 years’ experience in Biopharmaceutical Management in manufacturing, analytical and quality assurance in a leading biopharmaceutical company
- CMO management experience is preferred
- You have experience in sterile manufacturing of BioPharma
- You have experience in working in teams of an international/intercultural environment.
- You are fluent in English.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
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