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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Quality Director


Reference:JCAO2012 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Director, QA Manager, Qualified Person

Our client a global healthcare company are currently seeking a Quality Director to join their team The Quality Director is a key member of the organization who will lead strategic and operational performance of the Quality department. The Quality Director will be the most Senior position in Quality Department and successful candidate will be responsible for leading a team of managers and quality professionals


Role/Responsibilities:

  • Proactive contribution to discussions on quality topics and deliver quality improvements.
  • Assuring site metrics are at optimum levels and grant immediate strategies for metrics needing improvement.
  • Assuring Site Quality Systems are compliant to Health Authorities and company expectations/guidelines.
  • Maintaining professional and technical knowledge by attending educational workshops, reviewing professional publications, and participating in industry association.


Skills/Experience:

  • Wide breadth and depth of knowledge in Regulatory requirements, GMP/GXP / Biocontainment / SOPS.
  • Demonstrable record of accomplishment with skills and experience gained in a similar position(s), at a similar level.
  • Comprehensive knowledge and experience of EU Good Manufacturing Practice (GMP) and Quality Assurance, including products and processes used in the manufacture of licenses such as SAPO 2008
  • Significant practical experience of manufacturing and filling operations, ideally including biological products.
  • Strong leadership/team management skills and experience.
  • Experience of preparing for and managing Ireland (or equivalent standards) Regulatory Inspections and Internal & External audit experience
  • Experience in manufacture of Generics and Biopharmaceuticals is preferred.
  • QC Analytical experience preferred.


For further information please contact James Cassidy [email protected] or call in confidence 0860204322