Quality Director

2 weeks 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 Director (Biologics QP).

This pivotal role will ensure the compliant delivery of the organisation's global programmes by overseeing key external partners and ensuring adherence to global regulatory standards.

Key Responsibilities (not limited to): 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.
Ensure compliance with Good Manufacturing Practice and Good Distribution Practice regulations for subcontracted facilities.
Support client interactions and resolve packaging, labelling, and regulatory issues.
Lead audits, regulatory inspections, and address any observations.
Develop and manage key performance indicators for external partners and mentor 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.

If you are interested in this opportunity, please send your up-to-date CV to or call Oliver on

Seniority Level Director Employment Type Full-time Job Function Quality Assurance Industries: Pharmaceutical Manufacturing and Biotechnology Research #J-18808-Ljbffr

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