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AbbVie Ireland

European Lead, Commissioning & Qualification

AbbVie Ireland

  • Cork / Sligo / Dublin
  • Not disclosed
  • Permanent full-time
  • Updated 07/12/2017
this job is expired
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Description

We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Rede...

 

We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.

We are currently sourcing a European Lead, Commissioning & Qualification to join our global Engineering team. In this role you will be responsibile for setting directions, providing guidance and managing the global commissioning and qualification (C&Q) program for the European (Ireland, Germany & Italy) and Singapore regions. 

You will collaborate with the R&D and manufacturing site leadership, and Site Quality teams to drive optimum and standardized C&Q approach across the European network while leading and providing directions and validation strategy for key capital projects in the European region.  In addition, you will benchmark with other bio-pharma companies to continue to enhance the overall C&Q program for achieving optimal program outcome

Key Responsibilities Include:

  • Collaborate closely with the C&Q Manager in US to set Vision and Strategy for the corporate C&Q program.
  • Implement corporate C&Q strategies.
  • Identify and implement continuous improvement ideas to enhance the program.
  • Assist in development and plan for C&Q budget/estimates and other financial planning.
  • Provide leadership and oversight on C&Q for all European sites.

Education & Experience:

  • B.S degree in Chemical, Mechanical, or Electrical Engineering
  • Masters Degree in Engineering or MBA preferred
  • Minimum 10 years of experience in Pharmaceutical/bio-pharmaceutical industry
  • Minimum 7 years of experience in leading C&Q programs, and experience with interfacing Regulatory/Quality or auditors
  • Minimum 5 years of experience with supervisory, project management and budget management are required
  • Leadership of other technical professionals and experience in leading cross-functional teams with results-orientation.  Skilled in the strategy development, initiation, selection, coordination and management of projects and have ability to solve unique problems.
  • Knowledge of regulations and standards affecting devices, biologics and pharma products.  Strong working knowledge of ICH, ISO, US CFR and EU regulations.
  • Knowledgeable with latest industry standards and guidelines on C&Q, including ISPE/ASTM
  • Strong interpersonal and communication skills (verbal/written)
  • Strong negotiation skills
This role can be based in Dublin, Sligo or Cork

Ref: 1707844
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AbbVie Ireland

AbbVie Ireland

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