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Customer Relations and Quality Assurance Manager

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 our team, you will be responsible for ensuring the highest quality standards in our production processes and maintaining compliance with international regulations.

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 production processes and ensure effective communication with clients and markets.
  • Develop and maintain strong relationships with clients across geographies, ensuring their needs are met and exceeded.
  • Support biologics CMC regulatory submissions and interface with QA, technical teams, and external collaborators.
  • Plan and qualify new facilities, ensuring compliance with GMP requirements.

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 team is dedicated to delivering high-quality services to our clients, enabling them to reach patients faster. We are committed to being compliant with clients from all geographies and strive to provide exceptional service to our clients and candidates.