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Senior Quality Release Manager
vor 1 Monat
Biogen Idec is seeking a highly skilled and experienced Senior Quality Release Manager to lead the commercial release team and ensure the continuous supply of compliant medicinal products to approved markets. The successful candidate will be responsible for managing the release process, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to drive quality and continuous improvement.
Key Responsibilities
- Manage the commercial release team and ensure timely completion of release packages for EU/US products.
- Collaborate with cross-functional teams to drive quality and continuous improvement initiatives.
- Ensure compliance with regulatory requirements, including cGMP, EU/FDA regulations, and serialization and data integrity requirements.
- Identify and drive improvements/updates of GMP documentation related to QE activities.
- Support local Quality system (change control, deviations, CAPAs, ...) as required.
Requirements
- Bachelor's degree in a scientific field (Pharmacy, Chemistry, Biology, Biochemistry, etc.).
- Minimum 10 years of experience in pharmaceutical or biotechnology industries.
- Experience in people management and ability to develop effective working relationships with internal/external sites and cross-functional project teams.
- Sound knowledge of cGMP requirements, EU/FDA regulations, and compliance.
Why Biogen Idec?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry, and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
