Release Director, Global External Quality Lead

vor 3 Wochen


Baar, Zug, Schweiz Biogen Idec Vollzeit
Job Overview

At Biogen, we are dedicated to finding therapies for neurological and rare diseases. As a key member of our team, you will play a crucial role in leading the commercial release team to ensure continuous supply of compliant Medicinal Products to approved markets.

About This Role

The Head of Release & RP - Global External Quality is responsible for managing the commercial release team and RP release delegates. You will be accountable for ensuring full release packages for EU/US products are complete and forwarded on time to the Qualified Person for EU/FDA certification. Your expertise will also influence the strategy of product manufacturing at Contract Manufacturing Organizations (CMOs) to sustain without disruption of the supply chain.

Your Key Responsibilities

* 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 CMOs 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 Health Authority inspection on site
* Manage Stakeholder as RP delegate for the commercial release

Requirements

To be successful in this role, you will require:

* A 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

What We Offer

We offer a competitive salary range of $140,000 - $200,000 per annum, depending on your level of experience and qualifications. Additionally, you will have access to a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.

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