Global Quality Assurance Lead

3 days ago


Dublin, Dublin City, Ireland Blackfield Associates Full time

Blackfield Associates is partnering with a leading global healthcare services organisation in the search for a quality professional to oversee key external partners and ensure adherence to global regulatory standards.

This pivotal role will ensure the compliant delivery of the organisation's global programmes by implementing a global quality assurance strategy, managing quality management systems and overseeing quality outputs during programme set-up.

  • Define and implement a global quality assurance strategy for the global programme team in collaboration with leadership.
  • Manage the development and compliance of Quality Management Systems for global programme processes.
  • Oversee quality outputs during programme set-up, including audits, technical agreements, and supplier assessments.

The ideal candidate will have extensive experience as a Qualified Person, with expertise in Biologics, Gene Therapy, or Cryogenic Storage environments. You will possess in-depth knowledge of European Union regulations such as 2001/83/EC, Annex 16, and Good Manufacturing Practice guidelines, and have a strong track record of managing global quality programmes.

A proven ability to collaborate effectively with cross-functional teams and build relationships with internal and external stakeholders is essential. Flexibility to travel as needed is required.

Seniority Level
  • Director
Employment Type
  • Full-time
Job Function
  • Quality Assurance
  • Industries: Pharmaceutical Manufacturing and Biotechnology Research


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