Head of Quality and Customer Experience
2 months ago
Job Summary:
We are seeking a highly skilled and experienced Quality Assurance and Customer Relations Director to join our team at Real Staffing Group. As a key member of our organization, you will be responsible for ensuring the highest level of quality and customer satisfaction in our Gene Therapy sector.
About the Role:
- 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.
- Ensure that transferring products meet and exceed manufacturing and regulatory requirements in China, the EU, UK, and the US.
- Develop and maintain strong client relationships across geographies.
- Stay updated on regulatory changes and market trends in China, the EU, UK, and the US that may impact products.
Responsibilities:
- Regulatory Compliance, Quality Management, Audit and Inspection, Risk Assessment, Training and Development, Documentation and Reporting, Continuous Improvement, etc.
- Supporting biologics CMC regulatory submissions.
- Leading scenario planning, options analysis, risk management activities.
- Interfacing with QA (Quality Assurance), technical teams, external collaborators.
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.
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