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Customer Relations and Quality Assurance Manager

2 months ago

Oxford, Oxfordshire, United Kingdom Real Full time

Job Summary:

We are seeking a highly skilled and experienced Quality Assurance and Customer Relations Director to join our team at Real. As a leader in the Gene Therapy sector, we are dedicated to delivering high-quality products and services to customers worldwide, enabling Drug Developers to reach patients faster.

About the Role:

The chosen candidate will work closely with the CTO/VP of Manufacturing and the wider CDMO team to optimize the way the team works, ensuring effective translation of topics related to manufacturing and Quality. This will involve disseminating information 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 manufacturing and regulatory requirements in China, the EU, UK, and the US.
  • Lead scenario planning, options analysis, risk management activities, and GMP requirements.
  • Interface with QA (Quality Assurance), technical teams, external collaborators, and support biologics CMC regulatory submissions.
  • Plan and qualify a new facility, and stay updated on regulatory changes and market trends in China, the EU, UK, and the US.

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:

At Real, we offer 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.