Quality Manager

This innovator is a late stage clinical biotechnology company focused on the discovery, development and commercialisation of novel protein immunotherapies, for the potential treatment of diseases that involve amyloid or cell adhesion. With 3 product candidates at various stages of clinical trials, the future of this organisation is looking bright given recent trial results. Due to continued positive trial results, this organisation are looking to recruit a new Quality Manager into the business that will be responsible for assisting in the set up of their Quality Management Systems/Operation here in Dublin.

The Position:

  • Support for delivery of the PAI readiness programme for QA GMP operations
  • Assisting QMS development, including GMP systems, processes and SOP preparations
  • Providing QA support to stakeholder departments for GMP activities associated with clinical and commercial system development
  • Supporting QA change control and GMP audit management systems and other QMS activities and tasks, including CAPA followups
  • Assisting the Quality Agreement review process, as requested
  • Supporting qualification/validation activities relevant to GMP, including IT and data integrity reviews, as required
  • Supporting the preparation of Quality Management Reviews and Quality KPIs/metrics information
  • Other duties as assigned

The Person:

  • Bachelor’s degree in a health science or equivalent. Postgraduate qualification(s) desirable
  • 6+ years of experience within the pharmaceutical or preferably the biotechnology industry
  • 5+ years of experience working within Quality. Good knowledge and understanding of Quality/GxP legislation, including GMP/GDP regulations and guidelines

To learn more apply on line or call Shane Browne HRM on +353 1 632 18 65

Salary: On Application Location: Dublin South