Director of Biologics Quality
3 days ago
We are seeking an experienced quality professional to join our client in the role of Quality Director (Biologics QP). This position 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.
In this role, 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.
Key Responsibilities:
- 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.
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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