A start-up Biopharmaceutical company based in Dublin, focused on developing and commercializing drugs, is currently recruiting for a Quality Director. This position will be responsible for QMS implementation and management as well as oversight of GDP practices. This is a career changing opportunity within a company that is building a strong pipeline of Orphan Drugs. If you are looking to put your stamp on a Quality function within a niche area, then this is the perfect opportunity for you!

Responsibilities

• Provide leadership and build up a European Quality function.
• Lead Heath Authority audits and ensure all GMP/GDP licenses are obtained
• 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
• 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
• Previous experience in Biologics or Pharmaceuticals is necessary

The Next Step for you…

Should this position be of interest to you please forward your CV to Emma Wickham from Next Generation Recruitment or alternatively call on the main line on +353 1 6629120. 

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