Quality Assurance Specialist - Biotech GMP

Quality Assurance Specialist - Biotech GMP

Job Title: Quality Assurance Specialist - Biotech GMP
Contract Type: Permanent
Location: Stevenage
Salary: up to £45,000 DOE plus excellent benefits package
Start Date: 2019-12-16
Reference: 46006
Contact Name: Sue Wood
Contact Email:
Job Published: December 16, 2019 13:38

Job Description

A cutting-edge biotech is recruiting for a Quality Assurance Specialist to join a state-of-the-art Cell & Gene Manufacturing Centre based in Stevenage.  The company are a leading the way in the commercialisation of cutting-edge therapies that are now advancing through the clinical trial phases that are manufactured at their Stevenage site.  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 leading a mixture of hands on duties with strategic input into longer development and evolution of quality management systems.  With the responsibility for taking the lead on certain projects, taking them through the entire life cycle.
The purpose of the role is to develop and maintain the QMS which includes taking part in process mapping along with the associated procedures that control key quality and business processes.  Taking a strategic role in the design and implementation of processes and governance structures to ensure consistent compliance to GMP.    Being visible in the activities so you are the first point of contact for any questions within the QA Team.
As a Specialist you will also oversee the interactions between collaborators and the company, acting as the key point of contact for a defined collaborators.  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.