Senior Manager, Program Quality
An exciting opportunity has arisen for a Senior Manager of the Quality Program, you will be responsible for the coordination of quality input for the company's programme portfolio. You will work various stages during product launches. This is a remote role based within Europe.
- Quality person for internal program teams with regard to Quality topics of the relevant product portfolio during new product launch preparation, R&D as well as clinical and commercial manufacturing of Bio Similars.
- End to end management of Quality tasks for internal Project Teams.
- Give input and consultancy for project related validation activities and commercial manufacturing activities in alignment with commercial quality.
- Initiate and contribute to trouble shooting, as applicable
- Identify gaps and ensures mitigation by addressing it to the relevant functions
- Responsible that quality aspects are embedded in the routine program of the company
- When launching new products Lead projects or parts of the projects, or be a team member in special projects
Skills and Requirements
- First Degree / University Degree (University) in Biology, Biotechnology, Chemistry, Pharmaceutical Science or equal.
- 5-8 years relevant experience in GMP environment of Biotechnological Products
- Very good understanding and insight into the different aspects of quality functions like QC, QA, Quality Systems, Compliance, Microbiology, Documentation etc.
- Exposure to International working environment
- Fluent in English
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