Sr. Quality Release Lead

SUMMARY:

Act as Responsible Person (RP) delegate for Commercial Biologics Drug Substances (DS), Parenteral Drug Products (DP), Parenteral Finished Goods (FG) technical release or Active Pharmaceutical Ingredients (API), Pharmaceutical Drug Products, Pharmaceuticals Finished Goods (FG) technical release, and perform the certification of Finished Goods for the identified Market as well as import/export release to Switzerland as per Swiss Regulation (812.212.1) and European Directive 2001/83/EC, 2017/1572 as well as delegated regulation 2017/1569.
The RP release delegate is responsible for ensuring that each individual batch has been manufactured in compliance with laws in force in the country of destination, in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP).
Act as RP Release delegate (Fachtechnisch Verantwortliche Person) for Switzerland for both Biogen International GmbH and Biogen Swiss Manufacturing GmbH, in the meaning of articles 5, 10 and 14 of the Swiss Ordinance on authorizations relative to medicinal products (812.212.1). As such Responsible Person, she / he is authorized to give directives (also towards management) in her / his area of responsibility.
The incumbent can also serve as a disposition package and CoC Preparer to support other RP delegates or QPs in product certification.
The incumbent also serves as a Release Quality representative for change control evaluations and Release Quality decisions on deviations records.
This position covers all externally manufactured products ensuring maintenance of product supply to the market.

REQUIREMENTS;

A minimum of 6 years of experience in similar position 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 clinical products manufacturing and/or regulatory is an asset. Knowledge of medical device regulations and manufacturing is a plus.
Ability to develop effective working relationships with internal/external sites and cross-functional project teams.

Contact: Alba Jansa +41 61 282 22 13