Experience Confirmed (4-5 years)
Our client, a world leading Biotech company, is currently looking for their future CMO Global Quality Manager.
- 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.
- To evaluate the performance of contractors and the identification, negotiation, implementation and follow-up of process and systems improvements.
- To manage the quality management of the product lifecycle management in relation with contract manufacturing, artworks and support to asset functions such as review and approval of regulatory filings.
- To be the point of contact with key/critical CMOs, establishing the appropriate relationship and is a member of the internal Virtual Plan team.
- Minimum Bachelor’s degree, Master degree preferred, in a scientific topic (Pharmacy, Chemistry, Biology, Biochemistry etc.).
- A minimum of 5 years of experience in pharmaceutical or biotechnology industries.
- Understanding of cGXPs, quality systems and regulations (FDA and EU, knowledge of Japanese or other geographies’ regulations is a plus).
- Knowledge of medical device regulations and unit operations for manufacturing of either parenteral or pharmaceuticals, is a plus.
- Experience in project management and ability to develop effective working relationships with internal/external sites and cross-functional project teams.
- Good negotiation skills.
- Fluent English skills required, other languages a plus.