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QA Director, Europe

Location: Dublin
Experience:10+ Years
Job Type:Permanent
Salary:Not Disclosed
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May be suitable for: QA Director

The QA Director, Europe will be responsible for ensuring the company’s GMP and GDP processes and systems are in place to meet or exceed the European Regulatory Authorities’ requirements.


  • Act as the Responsible / Qualified Person for the local business, ensuring the required cGMP and cGDP licenses are secured and maintained.
  • Lead the local QA team, providing direction and development.
  • Ensure that Health Authority Inspections are appropriately led and managed, as well as other needs and interactions with the relevant bodies.
  • Implement and maintain training programs for GMP and GDP.
  • Keep Global QA and local stakeholders are kept informed of the relevant activities and align the Global Quality Strategies with local / regional business strategies.
  • Responsible for the development and implementation of Quality Management System (QMS) for GMP and GDP regulations and standards, in relation to the scope and direction of the local business.
  • As required, conduct the audit and qualification activities for vendors.


  • University degree in Pharmaceutical Sciences, or related scientific discipline.
  • Over 10 years’ relevant experience with an international organization developing pharmaceutical, biotechnology, or gene-therapy products.
  • Qualified / Responsible Person experience for the local market.
  • Leadership / Management experience preferred.
  • Proven ability to effectively communicate with the regulatory bodies (e.g. HPRA and EMA) and support regulatory submissions.

If you would like further Information you can contact the recruiter directly:

James Oakes | Tel: +353 (0) 1 507 9258


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