Quality Assurance Manager

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
• Organize and deliver QA related training and deliver basic GMP training

Requirements:
 

• 8+ years expereince within a qulity assurance role in a GMP environemnt 
• Expereince supporting the manufacturing of ATMPs
• Working knowledge of GMP relating to sterile production and aseptic techniques
• Evidence developing a PQS involoving a eQMS 
• Expereince writing and reviewing GxP documents 
• Auditing expereince is preferred