Customer Relations and Quality Assurance Manager

2 months ago


Oxford, Oxfordshire, United Kingdom Real Staffing Group Full time

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 the 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.
  • Lead scenario planning, options analysis, risk management activities.
  • Interface with QA (Quality Assurance), technical teams, external collaborators.
  • Plan and qualify a new facility.

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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