Quality Assurance Manager

4 days ago

Oxford, Oxfordshire, United Kingdom Real Staffing Full time
Job Title: Head of Quality Assurance - Production

Our client, a leading Gene Therapy company, is seeking a highly skilled Head of Quality Assurance - Production to join their team. As a key member of the CDMO team, you will be responsible for ensuring the highest quality standards in manufacturing and regulatory compliance.

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 manufacturing and regulatory requirements in China, the EU, UK, and the US.
  • Collaborate with the CTO/VP of Manufacturing and the wider CDMO team to optimize the way the team works.
  • Lead scenario planning, options analysis, risk management activities, and GMP requirements.
  • Interface with QA, technical teams, and external collaborators to ensure compliance.

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:

Our client offers a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.

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