Quality Compliance Specialist
4 days ago
As a Quality Director (Biologics QP) at Blackfield Associates, you will play a crucial role in ensuring the compliant delivery of our client's global programmes by overseeing key external partners and adhering to global regulatory standards.
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
- Full-time
- Quality Assurance
- Industries: Pharmaceutical Manufacturing and Biotechnology Research
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