Your new company

A pioneering biopharmaceutical company dedicated to transforming the lives of patients with severe immune and inflammatory diseases. Their mission is to harness the power of cutting-edge cell therapy technology to develop innovative treatments that restore immune balance and provide long-lasting relief. They are committed to excellence, collaboration, and pushing the boundaries of science to create life-changing therapies.

Your new role

This high-growth biotech is seeking an accomplished and energetic professional to lead its Quality team. In this role, you will be responsible for designing, implementing, and continuously improving quality systems and processes to comply with regulatory standards (FDA and MHRA), support clinical development, and prepare for commercialization. Your expertise will ensure that the company's products meet the highest standards of quality and safety.

What you'll need to succeed

- Extensive expertise in Quality requirements for biotech or pharmaceutical products, specifically in cell and gene therapy manufacturing.
- At least 10-15 years of experience in quality assurance within the biologics or cell/gene therapy industries, with a minimum of 10 years in a leadership capacity.
- Proven knowledge of GxP, FDA, MHRA, EMA regulations, and other international regulatory standards for biologics and cell therapies.