Quality Assurance and Customer Relations Director

6 days 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 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: Ensure compliance with all relevant regulations and standards.
  • Quality Management: Develop and implement quality management systems to ensure high-quality products.
  • Audit and Inspection: Conduct regular audits and inspections to ensure compliance and identify areas for improvement.
  • Risk Assessment: Identify and mitigate risks associated with product development and manufacturing.
  • Training and Development: Provide training and development opportunities to ensure team members have the necessary skills and knowledge.
  • Documentation and Reporting: Maintain accurate and up-to-date documentation and reporting systems.
  • Continuous Improvement: Identify areas for improvement and implement changes to ensure continuous improvement.

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:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

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