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Quality Assurance and Customer Relations Director

2 months ago

Oxford, Oxfordshire, United Kingdom Real Staffing Full time

Job Summary:

We are seeking a highly skilled and experienced professional to join our team as a Head of Quality Assurance - Production at a leading Gene Therapy company. As a key member of the CDMO team, you will be responsible for ensuring the highest quality standards in manufacturing and regulatory compliance across various geographies.

Key Responsibilities:

  • 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 and ensure effective translation of topics related to manufacturing and Quality.
  • Ensure that transferring products meet and exceed manufacturing and regulatory requirements in China, the EU, UK, and the US.
  • Lead scenario planning, options analysis, and risk management activities to drive business growth and success.
  • Interface with QA, technical teams, and external collaborators to ensure GMP requirements are met.
  • Support biologics CMC regulatory submissions and plan and qualify new facilities as needed.

Requirements:

  • Either a degree in a relevant field or equivalent practical track record.
  • CMC/quality assurance and regulatory compliance experience in Cell/Gene Therapy or a mixture of these.
  • Fluency in either Mandarin or Cantonese and English.

About Real Staffing:

We are a leading staffing agency specializing in the Gene Therapy sector. Our mission is to connect talented professionals with top companies in the industry, enabling them to reach their full potential.