Are you looking for a new and exciting challenge? Do you enjoy supporting clinical trials that will transform the testing and use of new therapies for maximum patient benefit?
We are looking for an individual with drive, passion, and enthusiasm to join us as the Quality Manager for the newly created Therapy Acceleration Laboratory (TAL). The TAL is an exciting new venture to establish a state-of-the-art laboratory to support national, and international, Phase I, proof-of-concept experimental medicine clinical trials, through to registrational Phase III, precision medicine clinical trials. The TAL will provide complex genetic, phenotypic and histological analyses of human patient samples.
You will take the lead role in the development, implementation and deployment of the Quality Management System (QMS), Quality Assurance standards, and guidelines. You will be responsible for the maintenance and improvement of the QMS. This key role will ensure that systems are in place to gain, and maintain appropriate accreditation and certification including UKAS ISO17025:2017, Clinical Laboratory Improvement Amendments (CLIA), Human Tissue Act (HTA), Good Clinical Laboratory Practice (GCLP) and compliance with other regulatory body requirements. You will guide and support continuous process improvement activities within the TAL to ensure high quality performance and patient results.
You will hold BSc/MSc in biological sciences or a Biomedical Scientist qualification, a further professional qualification in quality management is desirable. You will have experience of working with a QMS and providing related training. It is essential you have previously supported ISO accredited laboratories or organisations including: writing and reviewing controlled documents and formal reports, leading non-conformity investigations and audits. Experience of verification and validation of methods and equipment and assay performance monitoring is essential.
This position is available full-time (37.5 hours per week) for 3 years in the first instance.
Applications for this vacancy are to be made online. You will be required to upload a CV and supporting statement detailing how you meet the selection criteria, as part of your online application.
The closing date for this position is 12.00 midday on Tuesday 28 June 2022.
We expect to hold interviews on Tuesday 5 July 2022.