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QA Director, Europe

Reference:JO-A006681
Location: Dublin
Qualification:Degree
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.

Responsibilities:

  • 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.


Requirements:

  • 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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