Gene Therapy Compliance Specialist

At Pure Resourcing Solutions, we are seeking an experienced Gene Therapy Compliance Specialist to join our team in Cambridge.

This is a unique opportunity to lead the Quality department and ensure compliance of process development in gene therapies. You will work closely with the QA Director and oversee a team of 3 QA Officers, deputising for the QA Director in their absence.

• Ensure our quality management system (QMS) is compliant with relevant standards, including those related to gene therapy products.
  
• Identify, investigate and correct any non-conformances or corrective actions (CAPAs).
  
• Lead site management review meetings, ensuring that all aspects of the QMS are up-to-date and compliant.
  
• Produce quarterly and annual quality reports, highlighting areas of success and improvement opportunities.
  
• Monitor the change control process, ensuring that all changes are properly documented and implemented.
  

To be successful in this role, you will need:

• A degree in a relevant life sciences discipline, such as biology, chemistry or biochemistry.
  
• Significant experience in the manufacture of cell and/or gene therapy products, with a strong understanding of regulatory requirements.
  

In return for your expertise, we offer a competitive salary of £80,000 - £100,000 per annum, depending on experience, plus a range of benefits, including:

• A comprehensive pension scheme.
  
• 25 days' annual leave, plus bank holidays.
  
• The opportunity to work with a leading company in the gene therapy sector.