Biologics Quality Director
3 days ago
We're seeking a highly skilled professional to fill the role of Biologics Quality Director at Blackfield Associates.
This position offers a unique opportunity to drive the success of the organisation's global programmes by overseeing key external partners and ensuring compliance with global regulatory standards.
About the Role:
In this role, you will be responsible for developing and implementing a comprehensive quality assurance strategy for the global programme team.
Key responsibilities include:
- 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.
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