Overview

Genomics England partners with the NHS to provide whole genome sequencing diagnostics and enables researchers to understand disease causes and develop new treatments. Customers and patients are central to our mission to refine, scale, and evolve genomic healthcare and research. We operate a blended working model with flexible patterns; most roles require coming into the office a minimum of 2 times per month, with variations by role and team leadership. Office locations: Canary Wharf, Cambridge and Leeds.

Responsibilities

• Provide Quality Management leadership within an allocated genomic service (e.g. NGIS, GS/APGP or other) to promote a continuous quality improvement programme and culture. Set clear quality goals, roadmaps/programmes of work and vision, in concert with the service planning cycle supported by objective evidence and technical understanding for the changes required.
• Extract, analyse and interpret data from multiple sources to assess quality performance across the Quality System and service processes; setting and revising key performance indicators and driving demonstrable improvement in a systematic manner with the service leadership.
• Ensure compliance with all Quality regulatory requirements within the genomic service, providing clear, insightful interpretation of developing, new and current regulations, built on detailed understanding of genomic data analysis and understanding of software design and control (in conjunction with the Quality Assurance team).
• Provide independent investigation and/or review of incidents, changes and validation/verification activities using product and process understanding, as required. Analyse trends and ensure prioritised action, including formal reporting, where required (post-market surveillance).
• Work in conjunction with other assurance functions (e.g. Data Governance, Clinical Safety, Quality Assurance) to develop an internal and external supplier audit programme that assures compliance and drives continuous improvement through simplified and effective processes.
• Maintain the technical file, Schedule of Accreditation and associated registration records (as relevant to the Service) including supporting rationales where changes are made at the boundaries of intended use, through the deployment of AI/ML and/or changes which impact the service accreditation/registration (e.g. performance evaluation/accreditation/flexible scope).
• Be the point contact for the Service with regulatory parties (e.g. UKAS, MHRA and BSI) leading the Service through inspections, reportable incidents and consultations. Ensuring clear communication, risk assessment, business ownership, administration and coordination of responses.
• Maintain a documented Quality System which is compliant with ISO 13485, ISO 15189 and applicable government and regulatory guidelines, working in collaboration with the wider organisation and Quality colleagues. Author, review and approve the associated quality processes as required, supported by clear controls and monitoring mechanisms.
• Remain current with genomic data science developments to assure that the Service remains "state of the art" (ISO 14971) and addresses user needs gleaned from incidents and feedback received; ensure Service and Product requirements reflect the changes needed.
• Know and understand the meaning behind our virtues and leadership behaviours and embody them in all aspects of your role.

Qualifications and Experience

We are seeking people with a strong understanding of Quality regulation and standards around in vitro diagnostics, backed by a good understanding of genomic data analysis, potentially gained via a genetics or molecular biology, biomedical science degree or equivalent career experience, and some exposure to software engineering / development of digital services.

Benefits and Working Arrangements

Genomics England offers a benefits package including: 30 days holiday plus bank holidays, flexible remote working up to 30 days per year (approval required), blended working arrangements, enhanced maternity/paternity benefits, a defined contribution pension with generous employer matching, life assurance, learning budgets, professional subscriptions, employee recognition programme, subsidised gym membership, Headspace access and an Employee Assistance Programme.

We are committed to equal opportunities and a diverse, inclusive workplace. We welcome applicants regardless of disability, ethnicity, gender, gender identity, religion, sexual orientation, or social background. We do not tolerate discrimination, harassment or bullying, and we strive to remove barriers in our recruitment processes. Should you require adjustments to participate in the recruitment process, please discuss this with us.

Other

As part of our recruitment process, all successful candidates are subject to a Standard Disclosure and Barring Service (DBS) check. Applicants should disclose any unspent offences at point of application, as some offences may affect eligibility due to our healthcare-related work. Diversity and inclusion questions are answered anonymously and are not used in selection.