Quality Assurance Manager

1 month ago


Oxford, Oxfordshire, United Kingdom Real Staffing Full time

Head of Quality Assurance - Production

At Real Staffing, we're seeking a highly skilled professional to join our team as Head of Quality Assurance - Production. Our client, a leading company in the Gene Therapy sector, is committed to delivering high-quality products and services to customers worldwide, enabling Drug Developers to reach patients faster.

The chosen candidate will work closely with the CTO/VP of Manufacturing and the wider CDMO team to optimize the way the team works. This will involve effective translation of topics related to manufacturing and Quality, ensuring information is disseminated from Production to the teams and ultimately clients/markets.

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 the manufacturing and regulatory requirements in China, the EU, UK, and the US.
  • Collaborate with cross-functional teams to identify and mitigate risks, and implement process improvements.
  • Stay up-to-date on regulatory changes and market trends in China, the EU, UK, and the US that may impact products.

Requirements:

  • Relevant degree or equivalent practical experience.
  • CMC/quality assurance and regulatory compliance experience in Cell/Gene Therapy or a mixture of these.
  • Fluency in either Mandarin or Cantonese and English.
  • Strong leadership and communication skills, with the ability to lead scenario planning, options analysis, and risk management activities.

Additional Skills:

  • Regulatory Compliance, Quality Management, Audit and Inspection, Risk Assessment, Training and Development, Documentation and Reporting, Continuous Improvement.
  • GMP requirements and interfacing with QA (Quality Assurance), technical teams, external collaborators.


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