Clinical Quality Assurance Manager

1 day left

Company
Northreach
Location
London (Greater) (GB)
Salary
50000 - 60000
Posted
21 May 2021
Closes
20 Jun 2021
Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

An innovative and growing Biotechnology company based in West London is seeking the expertise of a Quality Assurance Manager that will specifically be working with the Clinical Operations and Immuno Translational Teams to develop and manage Quality Systems as it relates to GCP. 

This is a fascinating time to join the organisation after securing $83 million in Series A funding and becoming one with the team to develop a series of Cell & Gene Therapies globally. 

 

You will be responsible for: 

  • The Clinical Quality for clinical trial programs 
  • Ensure compliance of clinical studies with internal SOPs and clinical plans 
  • Develop and contribute into the day to day management of company GxP quality management system including document control, risk management and CAPA management 
  • Provide GCP / GCLP / GLP guidance to clinical project teams 
  • Participate and present at project meetings as Clinical Quality representative internally and externally 
  • Plan and implement regular GCP training and other quality related clinical training

Experience we are looking for 

  • Pharmaceutical / Biotechnology industry GCP 
  • Conducting internal and external audits 
  • Vendor oversights (CRO's) 
  • Quality Support for Cell of Gene Therapy (nice to have) 
  • Supporting Clinical Quality laboratories 

Qualifications and technical experience 

  • Bachelor’s degree in Life Science / Pharmacy / Regulatory 
  • Expert knowledge of GCP with understanding of ATMP 
  • Skilled at maintenance and monitoring of QMS in a growing environment (eQMS ideally) 
  • Understanding of Immunology 
  • Audit Training 

 

We see this position as a progressive role that will require someone to showcase their Clinical Quality experience. This role can be working from home and flexible for the right candidate. 

 

To find out more, please apply with your CV

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