Quality Assurance Specialist Biotech

Quality Assurance Specialist Biotech

Job Title: Quality Assurance Specialist Biotech
Contract Type: Permanent
Location: Stevenage
Salary: £400000 - £500000 per annum, Benefits: bonus, pension, life insurance, health insurance and other flexible benefits
Start Date: 2020-01-27
Reference: V-46052
Contact Name: James Hume
Contact Email:
Job Published: January 27, 2020 11:38

Job Description

A cutting-edge biotech is recruiting for a Quality Assurance Specialist to join their state-of-the-art Manufacturing Centre based in Stevenage that is continuing to expand resulting in multiple positions.  They are recruiting for someone to join their expanding team who can develop and maintain their Quality Management System for their multi occupancy manufacturing site.


The QA Specialist is a senior role within the team where you will be responsible for a mixture of hands on duties, leadership, and strategic input into development and evolution of their quality management systems.  For example alongside the day to day QA Activities you will have the responsibility for taking the lead on additional special projects in line with their continued expansion.


The core purpose of the role is to ensure GMP compliance is maintained at the site by ensuring the QMS is fit for purpose and up to date and operating as a quality assurance SME for the facility and operations.  Operating as a key point of contact for employees and collaborators to provide advice and guidance where needed.  As well as other day to day activities to ensure compliance is maintained such as internal audit porgammes, escalation, review of documentation and processes, and investigations. 


There is a strong strategic element to this role that includes taking a tactical role in the design and implementation of processes to ensure consistent compliance to GMP is maintained.  There is a focus on the QMS to ensure this is fit for purpose at all times which includes developing ways to maintain compliance as the centre grows.  Reviewing its performance on a regular basis to report on its continuing suitability and propose improvements to then be implemented.  As a senior member will also oversee the interactions between collaborators and the company, acting as the key point of contact for a defined collaborator.  You will work alongside the QA Lead to take a proactive approach to be sure the centre meets both regulatory and collaborator requirements.


Desired Skills and Experience:


You will need to have experience of quality assurance in a GMP regulated sterile manufacturing environment within the Biologics, ATMP, cell / gene therapy or similar sectors.  Prior experience in dealing with regulatory bodies and / or clients is an advantage but not essential.  You will need to have experience of managing quality management systems along to GMP to ensure they are fit for purpose and experience design of governance processes. 


The Company


The company are a centre of excellence that is at the forefront of creating a viable and sustainable cell and gene therapy industry.  Their headquarters are in central London where they have built a leading multidisciplinary team that has the ability to take a therapy from concept through the development cycle to the market.  They collaborate with both academia and industry and they are able to provide the scientific, clinical and commercial expertise needed to overcome the challenges that hinder the commercialization of these fast developing, cutting edge technologies.  They have constructed a purpose-built manufacturing centre which opened at the end of 2017 and immediately after opening additional funding was allocated for the centre to be doubled in size due to the demand for their services.  This currently consists of 12 (of which 6 very recently completed) clean room suites out for collaborators to use to manufacture advanced therapies for use in clinical trials.