Bioinformatics Quality Manager – London
2 Year Fixed-Term
To build on the success of the 100,000 Genomes Project, the Government tasked NHS England with support from Genomics England to launch a new NHS Genomic Medicine Service comprising a National Genomic Test Directory where 300,000 tests have been re-profiled and whole genome sequencing will be available for direct healthcare. Through 7 Genomic Laboratory Hubs this offers equitable access to the 55 million people in England to the latest genomic medicine and research. This will lead to faster diagnosis and personalised medicine.
The post holder is a bioinformatician with extensive experience working in NHS accredited laboratories. The post holder is responsible for maintaining and supporting the quality procedures for the bioinformatics pipelines that have been accredited against ISO 15189 within Genomics England. The post holder is accountable for the day to day supporting of the Bioinformatics QA processes, updating the Head of QA on the status of the Bioinformatics pipeline activities, incidents, non-conformities, audits and validation reports and being proactive for the facilitation of problem resolution and continuous improvements.
*Ability to carry out a gap analysis of existing pipeline processes against the ISO15189 and/or ISO13485 standard.
*Support the writing/ update of SOPs for all aspects of the pipeline and ensure they comply with the standards.
*Ensure that the bioinformatics pipeline (Operations and Development) complies with the ISO standards.
*Ongoing support for the bioinformatics team regarding the quality management system.
*Promoting a ‘continuous improvement’ culture.
*Constantly reviewing and seeking to improve KPIs and QA metrics performance and efficiency, meeting both current and future bioinformatics requirements.
*Carrying out and supporting technical audits and bioinformatics risk assessments for the operations and development procedures.
*Monitoring non-conformities, clinical safety incidents and deviations to make sure resolutions and appropriate CAPAs are in place
*Essential to have knowledge of working within an ISO accredited lab (preferably ISO 15189/ ISO9001 or ISO13485).
*Experience performing technical audits and risk assessments.
*Understanding of Bioinformatics code/algorithms and defining the root cause analysis in case troubleshooting of the pipeline is needed.
*Solid expertise of using continuous improvement methods to achieve QA objectives.
*Strong organisational, time management and planning skills.
*Self-motivated, with excellent ability to work on own initiative.
*Excellent team-working skills with willingness and ability to engage with others at all levels of the organisation.
*Ability to work under pressure without compromising the quality of work.
*Excellent written and interpersonal skills.
*Good attention to detail.
*Desirable to have knowledge of JIRA and Confluence.
There are some great benefits on offer with this role including a competitive salary, pension, generous holidays and more.
Please do not hesitate to contact Harvey Uppal at firstname.lastname@example.org or call (+44) 121 616 3407 to discuss this opportunity further.
Keywords: Bioinformatics, Quality, Manager, Genomics, ISO15189, ISO13485, SOP’s, NHS, Pipelines, Algorithms, Root Cause Analysis, Confluence, Jira, Operations, Support, London.
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Job Reference: BQMGEL_1562687387
Broadcast As: 18372
Salary To: Negotiable
Job Type: Full Time
Job Term: Permanent
Recruitment Consultant: Harvey Uppal