Quality Assurance Manager
1 month ago
Our client, a leading Gene Therapy company, is seeking a highly skilled Head of Quality Assurance - Production to join their team. As a key member of the CDMO team, you will be responsible for ensuring the highest quality standards in manufacturing and regulatory compliance.
Key Responsibilities:
- Develop and maintain a robust quality assurance system that adheres to international standards and best practices.
- Ensure that transferring products meet and exceed manufacturing and regulatory requirements in China, the EU, UK, and the US.
- Collaborate with the CTO/VP of Manufacturing and the wider CDMO team to optimize the way the team works.
- Lead scenario planning, options analysis, risk management activities, and GMP requirements.
- Interface with QA, technical teams, and external collaborators to ensure compliance.
Requirements:
- 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.
What We Offer:
Our client offers a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.
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