A clinical stage Cell Therapy company who are developing a unique and personalised approach to curing cancer are recruiting for a Quality Assurance Associate with expertise in GCP to join their team. As a company they are developing personalised cell therapies for the treatment of lung cancer and melanoma and have therapies entering the clinic complemented by an expanding translational pipeline.
The role of Quality Associate comes with broad exposure because they are launching two programmes across multiple sites which you will be a key part of. The focus of the role is to maintain their quality systems and processes for their QMS to ensure compliance to relevant regulations such as GCP.
You will be responsible for ensuring that clinical trials are run in compliance to ICH GCP regulations. As the QA Associate you will be working with the Quality manager and Director in the set up and the ongoing management of QMS to ensure activities are compliant to relevant regulations (GCP, ICH & HTA). This includes performing key routine duties such as document control, change controls, CAPA’s, deviation & investigation management, vendor qualification, and audits so that compliance is maintained.
You will have the responsibility for the review of documentation including the review, author and approval of SOP’s. Additional responsibilities includes taking part in cross functional projects as a QA representative which includes investigations to ensure root causes are identified and managed appropriately. There is a strong strategic aspect to the role where you will contribute to developing quality metrics and take the lead in initiatives to improve performance.
Desired Skills and Competencies:
For this opportunity, you will need to be have a BSc in a relevant life science with experience QA experience in a GCP environment with a good understanding of the regulatory framework. With experience of writing SOP’s and the review of GCP clinical documentation such as protocols, plans & reports. You will need to have experience of internal and external vendor audits with experience in the execution of these advantageous to your application. With experience in the handling of documentation, root cause analysis, CAPA’s and change controls.
The company are developing an approach to curing cancer that is different and enables them to meet unmet needs. They are developing novel immunotherapies that are targeting the protein markers that are unique to each person and expressed on the surface of each cancer cell. These are called Neoantigens and their approach is to sequencing data from each patient sample in conjunction with their bioinformatics platform to identify and then develop a cell therapy to target the neoantigens. This way a personalised treatment can be developed that targets only cancer cells not health.