Experience Senior (+5 years)
Our client, a world leading Biotech company, is currently looking for their future CMO Global Quality Manager.
- You will have to manage the Quality Activities with key/preferred manufacturing and testing partners (CMOs) for assigned products/projects by ensuring quality of product / process transfers, validations, issues investigations, tracking and resolution in a timely manner as well as process improvements.
- You will have to evaluate the performance the performance of contractors and the identification, negotiation, implementation and follow-up of process and systems improvements.
- You will be in charge of the product lifecycle management in relation with contract manufacturing, artworks and support to asset functions such as review and approval of regulatory filings.
- You will be the point of contact with key/critical CMOs, establishing the appropriate relationship and will be part of the internal Virtual Plan team.
- You have a Bachelor’s degree, or a Master degree in a scientific topic (Pharmacy, Chemistry, Biology, Biochemistry etc.).
- You have at least 6 years of experience in pharmaceutical or biotechnology industries.
- You have relevant experience in either manufacturing, development, quality or regulatory; Understanding of cGXPs, quality systems and regulations (FDA and EU, knowledge of Japanese or other geographies’ regulations is a plus).
- You are fluent in English.