Quality Assurance Manager

Stevenage, Hertfordshire, South East, England

Posted:65 days ago
Location:Stevenage, Hertfordshire, South East, England
Job Ref:BH-33780-1
Job Type:Permanent
Salary:£50000 - £65000 per annum
Expiry date:2/2/2023
Contact:Megan Tayler
Contact Email:megan.tayler@xplorelifescience.com
Xplore life sciences are recruiting for a QA Manager with specialist knowledge of Advanced Therapy Medicinal Products (ATMPs) to work with an exciting biotech who are focused on developing cutting edge cellular therapies.

Our client is delivering life changing therapies for their patients and looking for an experienced quality assurance manager who can develop and lead a risk based pharmaceutical quality system. 

Main Responsibilities 
  • Manage and perform QA duties to ensure manufacturing, testing and clinical trials activities comply with GMP, GCP, HTA and other regulatory requirements
  • Develop and lead a risk based pharmaceutical quality system (PQS)
  • Build and manage a small team of QA professionals 
  • Draft, review and approve Quality and GxP related documentation
  • Manage Product Specification Files for ATIMP’s
  • Organise and deliver QA related training and deliver basic GMP training
  • 8+ years experience within a qulity assurance role in a GMP environemnt 
  • Experience supporting the manufacturing of ATMPs
  • Working knowledge of GMP relating to sterile production and aseptic techniques
  • Evidence developing a PQS involving a eQMS 
  • Experience writing and reviewing GxP documents 
  • Auditing experience is preferred 

Apply now