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Senior Quality Manager - QMS

A start-up biopharmaceutical company based in Dublin, focused on developing and commercializing drugs, is currently recruiting for a Senior QA Manager. This company has a very strong pipeline of development stage drugs and has grown significantly over the last year. This position will be responsible to develop their European Quality function in relation to aspects of QMS implementation and Document Control. If you are looking for a new challenge and to get in at ground level within a start-up environment, then this will be the perfect role for you.

Responsibilities

  • Support the development and implementation of the long-term Quality strategy and provide overall quality oversight to GDP practices
  • Develop and embed a Quality culture into business processes
  • Manage quality compliance within network of CMO’s
  • Responsible for CAPA and non-conformance management
  • Contribute to the development of the annual Quality Plan
  • Conducts risk-based audits of service providers and internal systems – maintain audit files and tracking log.
  • Conduct QA review of draft GMP and GLP documents, when requested. 
  • Act as main contact during FDA /HPRA inspections, customer audits and other third party Quality System evaluations
  • Develop and implement training for relevant internal staff. Maintain training files and monitor compliance of staff GMP with training

Experience

  • Bachelor and/or Masters degree in a scientific related discipline
  • 7+ years of GMP/GDP experience
  • Experience in a virtual organisation or working with CMO’s is desirable