QA Manager - North London / Hertfordshire
Jason Johal at CK Science is recruiting for a Quality Assurance Manager to join a new and rapidly progressing group focused on developing immunotherapies for the treatment of cancer. This role will be twin based between their site in North London and Hertfordshire on a permanent basis.
The Company: Our client is an exciting new start-up focused on the development of the next generation of personalised immunotherapies to treat cancer. The company's origins are in ground breaking research at UCL, CRUK as well as the Francis Crick Institute, and they hope to use their cutting edge neoantigen driven immuno-oncology approach to rapidly advance transformational therapies into the clinic.
Location: This role will be split between their sites in North London and Hertfordshire. Their London site is based at an easily commutable distance by tube from Belsize Park or Gospel Oak, and also from Hampstead Heath Rail Station. Their site in Hertfordshire is also easily commutable from London (20 minutes by train) and a short distance from the station.
The Role: This is a key role as responsibly for initialising the company's QMS ensuring activities conform with regulatory requirements. As the company rapidly progresses to first in human clinical trials you will conduct QA duties and audits to ensure GMP/GLP compliance, as well as any other regulatory requirements relating to manufacture and clinical trials for cellular therapies and ATIMPs. This will include developing a document control system, change control, CAPAs, deviation and OOS reporting, calibration and maintenance, qualification and validation, internal audits and vendor qualification. You will also develop and review Quality and GxP related documentation, manage the Product Specification Files for ATIMP's, implement systems from a quality perspective to ensure ATIMP traceability and responsibility and ensuring efficient quality systems supporting logistical aspects of product and sample transport handling. Further responsibilities will include advising in the preparation of validation protocols and reports as well as the review of data generated in the execution of validation protocols and working closely with the manufacturing and QC teams to establish key manufacturing documentation in line with a Contract Manufacturing Organisation's own QM system.
Your Background: As this is a brand new role for a new company we require someone who is highly self motivated and someone who has a good “overall” view and experience of developing a QA system from scratch. We also need someone who is willing to pull up their sleeves to get stuck in and where problems arise will have the ability to solve issues quickly and accurately relying on their own skills and abilities. The ideal candidate for this role will have a working knowledge of regulatory requirements that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP's. They will also have an understanding of GMP, GCP, GDP and HTA requirements, experience of auditing key raw material suppliers as to GMP compliance, experience in vendor and site audits and experience of training staff.
For more information or to apply for this position, please contact Jason on 01438 723 500 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 44905 in all correspondence.