Head of Release & RP - Global External Quality

About This Role

As Head of Release & RP - Global External Quality you will be responsible for leading the commercial release team to ensure continuous supply of compliant Medicinal Product to approved market as well as to ensure their development.

You will act as Responsible Person (RP) delegate for Active Pharmaceutical Ingredients (API), Drug Substances (DS), Drug Products (DP) technical release and perform the certification of Finished Goods for the identified Market 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 package 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 the CMOs and to sustain without disruption of the supply chain.
• Contribute to technology transfer or improvements projects through establishment of needed release process update.
• Actively contribute to the Health Authority inspection on site.
• Manage Stakeholder as RP delegate for the commercial release.
• Identify and drive improvements/updates of the GMP documentation related to QE activities.
• Identify any compliance gap in Biogen processes and collaborate with appropriate stakeholder to fix the issue.
• Support local Quality system (change control, deviations, CAPAs, …) as required.
• Ensure adherence to serialization and data integrity requirements.

Who You Are

You are passionate about quality and continuous improvement and love developing people.

Required Skills

• Bachelor degree in the 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 fluent

Preferred Skills

• Master degree in the scientific field (Pharmacy, Chemistry, Biology, Biochemistry etc.).
• Fluent in German, Italian or French is an asset.
• Experience in clinical products manufacturing and/or regulatory is an asset.
• Knowledge of medical device regulations and manufacturing is a plus.

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.