Senior Quality Assurance Manager

3 days ago


Dublin, Dublin City, Ireland Blackfield Associates Full time

Blackfield Associates is partnering with a leading global healthcare services organisation to fill a key role.

This position is crucial for the compliant delivery of the organisation's global programmes by overseeing external partners and ensuring adherence to global regulatory standards.

Key Responsibilities (not limited to): Develop and implement a global quality assurance strategy in collaboration with leadership.
Create and maintain Quality Management Systems for 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.

Responsibilities:

  • Implement a global quality assurance strategy
  • Create Quality Management Systems
  • Oversee quality outputs
  • Ensure regulatory compliance
  • Lead audits and inspections
  • Mentor junior team members


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