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Bristol-Myers Squibb

Site Quality Director Biologics

Bristol-Myers Squibb

  • Dublin
  • See description
  • Permanent full-time
  • Updated 21/12/2017
this job is expired
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Description

BMS Cruiserath is seeking to recruit a permanent Site Quality Director.

 

Bristol-Myers Squibb has just completed the building of a new state of the art biologics manufacturing facility in Cruiserath, Dublin 15, approximately 1 billion$ investment. This new facility significantly increases Bristol-Myers Squibb’s biologics manufacturing capacity and plays a central role in its global manufacturing network. The site also serves as the global biological drug product release testing site through its Global Biologics Laboratory (GBL). 

BMS Cruiserath is seeking to recruit a permanent Site Quality Director. Reporting to the Head, Global Biologics Quality, Internal Sites, the Site Quality Director is a key leader within BMS Quality Biologics, will be part of the BMS Site Leadership team and will lead a team of over 100 personnel across QA, QC, Systems and Compliance.  

 The Site Quality Director will ensure that products manufactured, tested and released within the Cruiserath Biologics site comply with the registered quality specifications and the registration files in accordance with the expectations of Global Regulatory Health Authorities including EMEA and FDA and with BMS requirements. The Site Quality Director will oversee the implementation of the global drug product testing and release strategy and ensure compliance with the regulatory requisites of the markets in which the products are intended to be distributed.

Key responsibilities will include;

  • Directing all aspects of site quality programs, systems, operations and compliance activities.
  • Directing all aspects of the integration and implementation of the global drug product release testing strategy into the new manufacturing site with accountability for method transfer activities, drug product testing and lean labs implementation.
  • Overseeing the Qualified Person release for distribution in Europe, and ROW markets for products manufactured by or on behalf of BMS (internal and external sites).
  • Ensuring appropriate GMP Quality Systems are in place.
  • Ensuring site GMP required procedures are in alignment and in compliance with BMS Corporate Compliance and Quality Policies and Directives. 
  • Ensuring that deviations from procedures and specifications are investigated, resolved and documented.
  • Interfacing with Regulatory Agencies (FDA, EMA and foreign regulatory agencies) as necessary, leading site regulatory inspections and ensures compliance with the marketing authorization requirements. 

 A degree in science, engineering or related discipline is essential along with at least 10 years in a Quality leadership role in the Biopharmaceutical industry and with experience of leading large teams.  Demonstrated proficiency in interpretation of FDA and EMA cGMP regulations for biologics, as well as in-depth knowledge of regulatory requirements for filing Biologics in the US and Europe is required.

The candidate will have a track record of implementations of continuous improvement and of driving a culture of Quality throughout all parts of an organization.    

 The candidate will have demonstrated proficiency communicating and collaborating at a variety of levels and across divisions. In addition the successful candidate must have demonstrated success as a strong team leader who uses past experience to develop departmental staff through effective feedback and coaching.

Ref: R1120873
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Bristol-Myers Squibb

Bristol-Myers Squibb

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