Quality Manager

University of Oxford; Oxford; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading academic institution in Oxford is seeking a Quality Manager to develop and maintain the Quality Management System ensuring compliance with ISO standards. The ideal candidate will have a BSc/MSc in biological sciences or equivalent, experience in quality management, and skills in training others. This role focuses on supporting high-quality patient results within a state-of-the-art laboratory environment.

Qualifications

• Experience working with a Quality Management System.
• Familiarity with ISO15189 and CLIA standards.
• Ability to guide and train others on QMS.

Responsibilities

• Develop and implement the Quality Management System (QMS).
• Maintain and improve QMS for compliance.
• Lead continuous process improvement activities.

Skills

Quality Management System (QMS)

ISO accreditation knowledge

Process improvement

Document control

Auditing skills

Education

BSc/MSc in biological sciences

Biomedical Scientist qualification

Job description

Radcliffe Department of Medicine, MRC Weatherall Institute of Molecular Medicine, John Radcliffe Hospital, Headington, Oxford

We are looking for a Quality Manager with drive, passion, and enthusiasm to join us at the accredited Therapy Acceleration Laboratory (TAL). The TAL is an exciting 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 and currently holds UKAS ISO17025 accreditation.

Job Responsibilities

You will take the lead role in the development, implementation and deployment of the Quality Management System (QMS), Quality Assurance standards and guidelines and 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 UKAS ISO15189 Clinical Laboratory Improvement Amendments (CLIA). You will guide and support continuous process improvement activities within the TAL to ensure high quality performance and patient results.

Qualifications and Experience

You will hold BSc/MSc in biological sciences or a Biomedical Scientist qualification with experience of working with and training others on a QMS. Previous experience in supporting ISO accredited laboratories or organisations, including: writing and reviewing controlled documents and formal reports, leading non-conformity investigations and audits, is essential. Experience of verification and validation of methods and equipment and assay performance monitoring is also essential.