EU Head of Quality – QP

This company is one of the world’s leading biopharmaceutical companies. Through acquisitions and mergers, this company has expanded rapidly in its short history and now boasts more than 10,000 employees, and offices in more than 40 countries. This organisations growth strategy is to focus on developing and marketing innovative specialty medicines for symptomatic conditions to meet significant unmet patient needs. Their strategic priorities are to drive optimum performance of their existing products, enabling access to these medicines for patients today and building their pipeline through research and development and business development delivering access in the future for patients. Due to continued expansion, an exciting new position has arisen in the organisation for an EU Head of Quality – QP to join their growing Quality team.

The Position

The Head of EU Quality will be responsible for designing and executing the strategy for compliance to good manufacturing and good distribution practices for all internal and external operations for small molecule, biologic and device products / services in Europe.

They will hold ultimate responsibility for EU regional product release and will therefore be required to be and practice as a “Qualified Person”. In addition, this leader will demonstrate strong vendor management qualities as well as the ability to evaluate and recommend new external partners/suppliers in the EU region, identifying risks and implementing changes to ensure compliance to company standards.

This leadership role also includes responsibility for associated compliance activities; training, documentation, auditing, including implementation of additional applicable regional expectations with support from the other quality organisations.

As part of their role they will drive and establish strong partnerships (internally & externally) to ensure clear requirements and expectations are defined and executed to enable release of products in the EU market while leading and developing a strong team located across Europe.

The Person

  • Degree in technical discipline such as biochemistry, chemistry, engineering
  • Advanced degree in complimentary field of study
  • Extensive experience in the biotechnology and/or pharmaceutical industry, preferably both
  • Eligible to practice as a Qualified Person
  • Experience leading international teams in multiple regions
  • Experience with small and large molecule production processes, aseptic processing, as well as tableting and controlled substances is desired
  • Over sight of CMO operations, packaging and labelling and / distribution
  • Proven people manager and leader capable of developing people and teams with proven management experience
  • Track record of effective QA leadership for both internal and external production facilities and product release
  • Experience leading, training and/or implementing root cause analysis and effective investigation practices
  • Understands regulations pertaining to licensing, import/export, scheduled/controlled drugs, and transportation requirements.

To learn more apply online or contact Shane Browne on +353 1 632 1865.

Salary: On Application Location: Dublin City Centre