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Global Quality Compliance Specialist

1 week ago

Dublin, Dublin City, Ireland Blackfield Associates Full time

Blackfield Associates is seeking a seasoned professional to fill the position of Global Quality Compliance Specialist.

This role offers a unique opportunity to drive the success of the organisation's global programmes by ensuring compliance with global regulatory standards.

About the Position:

In this role, you will be responsible for developing and implementing a comprehensive quality assurance strategy for the global programme team.

Key responsibilities include:

  • Developing and implementing a global quality assurance strategy for the global programme team in collaboration with leadership.
  • Managing the development and compliance of Quality Management Systems for global programme processes.
  • Overseeing quality outputs during programme set-up, including audits, technical agreements, and supplier assessments.
  • Ensuring compliance with Good Manufacturing Practice and Good Distribution Practice regulations for subcontracted facilities.
  • Supporting client interactions and resolving packaging, labelling, and regulatory issues.
  • Leading audits, regulatory inspections, and addressing any observations or findings.
  • Establishing and managing key performance indicators for external partners and mentoring junior team members.

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.