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Head of Quality and Customer Experience
2 months ago
Job Summary:
We are seeking a highly skilled and experienced professional to join our team as a Head of Quality Assurance - Production at a leading Gene Therapy company. As a key member of the CDMO team, you will be responsible for ensuring the highest quality standards in manufacturing and regulatory compliance across various geographies.
Key Responsibilities:
- Develop and maintain a robust quality assurance system that adheres to international standards and best practices.
- Collaborate with the CTO/VP of Manufacturing and the wider CDMO team to optimize the way the team works and ensure effective translation of topics related to manufacturing and Quality.
- Ensure that transferring products meet and exceed manufacturing and regulatory requirements in China, the EU, UK, and the US.
- Lead scenario planning, options analysis, and risk management activities to drive business growth and improvement.
- Interface with QA, technical teams, and external collaborators to ensure GMP requirements are met.
- Support biologics CMC regulatory submissions and plan and qualify new facilities as needed.
Requirements:
- Either a degree in a relevant field or equivalent practical track record.
- CMC/quality assurance and regulatory compliance experience in Cell/Gene Therapy or a mixture of these.
- Fluency in either Mandarin or Cantonese and English.
About Real Staffing:
We are a leading staffing agency specializing in the Gene Therapy sector. Our mission is to connect top talent with innovative companies like yours. If you're looking for a challenging and rewarding role, we'd love to hear from you.