Overview

Our mission is to continue refining, scaling, and evolving our ability to enable others to deliver genomic healthcare and conduct genomic research. We are accelerating our impact and working with patients, doctors, scientists, government and industry to improve genomic testing, and help researchers access the health data and technology they need to make new medical discoveries and create more effective, targeted medicines for everybody.

Role: The Service Quality Partner (software focus) is responsible for partnering with the software engineering and infrastructure teams to lead and manage all aspects of Quality support, Quality Improvement, plus compliance and regulatory management within these areas of Genomics England.

Responsibilities

• Provide Quality Management leadership for software and infrastructure activities within Genomics England, ensuring the translation of software as a medical device requirements across Services (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 leadership team 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, in concert 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 prioritized action, including formal reporting, where required (post-market surveillance).
• Work 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.
• Support the maintenance of technical files, Schedule of Accreditations and associated registration records (as required across the Services in conjunction with other Quality team members) 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 Quality point of contact for issues relating to the software development lifecycle with regulatory parties (e.g. UKAS, MHRA and BSI) supporting the Services through inspections, reportable incidents and consultations. Ensure clear communication, business ownership, administration and coordination of responses.
• Maintain a documented Quality System which is compliant with ISO 62304, 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 & Experience

• Strong experience and/or qualifications gained in software engineering and digital service development, ideally within a software house or business.
• Understanding of engineering controls and metrics, familiarity with industry standards such as IEC 62304.
• Genomics experience is desirable.

Location and Working Arrangements

Genomics England operates a blended working model with hybrid working. Most roles expect to come into the office a minimum of 2 times per month, with variation by role and agreement with the team lead. Office locations: Canary Wharf, Cambridge and Leeds.

Salary & Benefits

Salary from: £51,000. Benefits include:

• Generous Leave: 30 days' holiday plus bank holidays, additional leave for long service, and up to 30 days remote working abroad annually (approval required).
• Family-Friendly: Flexible working, enhanced maternity/paternity and shared parental leave benefits.
• Pension & Financial: Defined contribution pension (Genomics England matches up to 10%), Life Assurance (3x salary), Give As You Earn.
• Learning & Development: Individual learning budgets, support for training/certifications, reimbursement for one annual professional subscription (approval required).
• Recognition & Rewards: Employee recognition programme and referral scheme.
• Health & Wellbeing: Subsidised gym membership, Headspace access, and Employee Assistance Programme, eye tests, flu jabs.

Equal Opportunities

Genomics England is committed to an inclusive workplace with equity, diversity and inclusion best practice. We welcome applications from all backgrounds and ensure fair treatment regardless of age, disability, gender identity, religion, sexual orientation, or social background. If adjustments are needed during recruitment, please discuss with us. All successful candidates are subject to standard screening and disclosures as required by law.