GCP Compliance and Quality Assurance Manager

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford

Oxford, South East England, United Kingdom

Salary: Grade 8: £40,792 - £48,677 p.a.

We have an exciting opportunity for a full-time vacancy for a suitable candidate to fulfil a challenging and rewarding role with the Quality Assurance Team of the Oxford Clinical Trials Research Unit (OCTRU).

OCTRU is one of 51 UKCRC registered Clinical Trials Units that runs all phases of clinical trials across multiple areas of medicine. The OCTRU office is based at the Botnar Research Centre in Headington, Oxford which forms part of the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS).

As GCP Compliance and Quality Assurance Manager, you will be responsible for ensuring that OCTRU’s QA team undertakes routine audits and central monitoring activities on internal systems which are integral to the quality of trial activities with the ultimate aim to have continual improvement and compliance with requirements on the growing portfolio of complex trials under the direction of the OCTRU’s Head of Regulatory Affairs and Quality Assurance. You will also help support with the audit of Standard Operating Procedures (SOPs) and to ensure review of policies and SOPs in a timely manner.

You will have a degree in a biomedical or related sciences subject, or other relevant qualification, whilst having significant experience of working with GCP and supporting documents. Considerable experience of monitoring and/or auditing clinical trial activities for compliance with GCP and clinical trial legislation and report writing is also essential, as is having critical and intelligent attention to detail and high standards of accuracy.

A diploma in Quality Assurance or equivalent and membership of a QA Professional group such as RQA (formally known as BARQA) would be desirable, as would familiarity with ISO 9000:2000; ISO 9001.

This is a full-time fixed-term appointment for 2 years.

A lower grade offer may be made (Grade 7: £32,236 - £39,609 p.a.) with commensurate reduction in responsibilities if a suitable candidate cannot be found to fill the Grade 8 position

You will be required to upload a supporting statement and CV as part of your online application.

For informal enquiries, please contact Dr Joanna Black on 01865 572396 or email: joanna.black@ndorms.ox.ac.uk.

The closing date for this position is 12.00 noon on Thursday 28 February 2019. Interviews are expected to be held on Wednesday 13 March 2019.

Please apply via recruiter’s website.

Quote Reference: University of Oxford-itox_ac-139196