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Director of Quality Assurance
2 months ago
Real Staffing is seeking a highly skilled Head of Quality Assurance to join our client's team in the Gene Therapy sector. As a leader in delivering high-quality products and services, our client is committed to enabling Drug Developers to reach patients faster.
The successful candidate will work closely with the CTO/VP of Manufacturing and the wider CDMO team to optimize the way the team works. This will involve effective translation of topics related to manufacturing and Quality, ensuring information is disseminated from Production to the teams and ultimately clients/markets.
The Head of Quality Assurance will be responsible for ensuring that transferring products meet and exceed manufacturing and regulatory requirements in China, the EU, UK, and the US. This will involve developing and maintaining a robust quality assurance system that adheres to international standards and best practices.
Key Responsibilities- Management role or expertise in pharma/biotech
- Regulatory submission, clinical approval, or IND-enabling/approval experience
- QA / Manufacturing role
- Client relationships across geographies
- Ideally CDMO manufacturing/service agreement contracting/CRM
- Supporting biologics CMC regulatory submissions
- Ability to lead scenario planning, options analysis, risk management activities
- GMP requirements and interfacing with QA (Quality Assurance), technical teams, external collaborators highly desired
- Experience of planning and qualifying a new facility would be a plus
- Either a degree in a relevant field or equivalent practical track record
- CMC/quality assurance and regulatory compliance in Cell/Gene Therapy or a mixture of these
- Fluency in either Mandarin or Cantonese & English