Regulatory Affairs Director

2 days ago


Dublin, Dublin City, Ireland Blackfield Associates Full time

We are seeking a highly skilled Quality Director (Biologics QP) to join our team at Blackfield Associates. In this role, you will be responsible for ensuring the compliant delivery of our client's global programmes by overseeing key external partners and adhering to global regulatory standards.

As a Quality Director, you will define and implement a global quality assurance strategy, manage the development and compliance of quality management systems, and 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.

Responsibilities will include:

  • Defining 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.
  • Developing and managing key performance indicators for external partners and mentoring junior team members.

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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