Senior Release Manager

vor 2 Wochen

Baar, Zug, Schweiz Biogen Idec Vollzeit
About This Role

As a Senior Release Manager at Biogen, you will be responsible for leading the commercial release team to ensure continuous supply of compliant Medicinal Products to approved markets. You will also act as a Responsible Person (RP) delegate for Active Pharmaceutical Ingredients (API), Drug Substances (DS), and Drug Products (DP) technical release, and perform the certification of Finished Goods for identified markets as well as import release to Switzerland as per Swiss Regulation and European Directive.

What You'll Do

Manage the commercial release team and RP release delegates.
Ensure full release packages for EU/US products are complete and forwarded on time to the Qualified Person for EU/FDA certification.
Influence the strategy of the manufacturing of our products at Contract Manufacturing Organizations (CMOs) and sustain without disruption of the supply chain.
Contribute to technology transfer or improvements projects through establishment of needed release process updates.
Actively contribute to Health Authority inspections on site.
Manage Stakeholders as RP delegate for the commercial release.
Identify and drive improvements/updates of the Good Manufacturing Practice (GMP) documentation related to Quality Excellence (QE) activities.
Identify any compliance gaps in Biogen processes and collaborate with appropriate stakeholders to fix the issue.
Support local Quality systems (change control, deviations, CAPAs, ...) as required.
Ensure adherence to serialization and data integrity requirements.

Qualifications

Bachelor's degree in a scientific field (Pharmacy, Chemistry, Biology, Biochemistry, etc.).
A minimum of 10 years of experience in pharmaceutical or biotechnology industries.
Experience in the pharmaceutical industry (small molecules and/or biotechnology and/or aseptic filling).
Sound knowledge of cGMP requirements, EU/FDA regulations, and compliance.
Experience in people management and ability to develop effective working relationships with internal/external sites and cross-functional project teams.
English fluency.

Why Biogen?

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.

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