Quality Assurance Manager (QAM) – Translational Support Laboratories

About the role

We have an exciting opportunity for a Quality Assurance Manager to join Oxford Cancer, a city-wide research initiative and partnership between Oxford University, Oxford University Hospitals NHS Trust, Thames Valley Cancer Alliance and the Oxfordshire Clinical Commissioning Group. We seek to harness Oxford’s world-leading cancer research from our growing network of 1,000+ members who are working in cancer-related fields. This network covers a range of disciplines, all with the core aim of facilitating collaboration to ensure rapid translation of scientific discovery to treatments for patients.

An important part of Oxford Cancer’s activity is the establishment and management of laboratories, services and facilities used by a variety of cancer researchers working on cutting edge, innovative and high impact projects. Collaborators include academics at Oxford and across the UK, as well as commercial and industry partners.

This position will require you to have a comprehensive understanding of clinical trials regulations, GCP, QA processes, GDPR, data protection act and all governance applicable to Oxford Cancers Translational Support Laboratories. You will need to proactively cultivate positive networks and relationships to the benefit of internal and external stakeholders.

This will involve providing QA oversight for staff working in laboratories processing, storing and analyzing clinical/patient samples. You will be responsible for ensuring that appropriate quality control processes are in place for all aspects of laboratory analysis. You will be required to conduct, document, and action risk assessments of proposed and ongoing projects. You will need to ensure that risks are appropriately identified and mitigations are proportionate and practical.

You will work closely with laboratory teams to ensure appropriate quality and laboratory management systems are in place. You will support the implementation of the QMS and LMS as required, including SOP training and assessment and delivery of process change. This position will also involve audit and inspection duties, including planning and conducting audits and reviews relevant to the needs of the activities of each laboratory, as well as participate in audits or inspections by external parties as required and support laboratories in preparing for external audits or inspections.

This is a full-time post based at Oxford Cancer, New Richards Building, Headington, Oxford, OX3 7LA, and is available on a three-year fixed term contract.

About you

You must hold a first degree in medical or life science.  You will have QA related/clinical research professional qualification and demonstrable experience in clinical research quality assurance including developing SOPs, conducting audits and monitoring activities to comply with high levels of GCP. You will have in-depth knowledge of clinical trial management and specifically the variety of regulatory standards that apply to different laboratory analyses. They should also have an in-depth working knowledge of existing UK clinical research structures, GCP, regulatory and ethical systems, as well as an understanding of the regulatory requirements for the collection and use of human tissue and other biological samples in clinical research. Experience of working in the academic/non-commercial research sector or working in a molecular biology/biochemistry laboratory and/or using patient derived samples would be advantageous.

Application Process

Applications for this vacancy need to be made online. You will be required to upload a supporting statement (setting out how you meet the selection criteria), a curriculum vitae and the names and contact details of two referees as part of your online application.

Only applications received by 12:00pm on Friday 16th June 2023 will be considered.

Committed to equality and valuing diversity