Company Description
Genomics England partners with the NHS to provide whole genome sequencing diagnostics. We also equip researchers to find the causes of disease and develop new treatments – with patients and participants at the heart of it all.
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.
Overall job purpose
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.
Job Description
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 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.
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 contact for issues relating to software development lifecycle with regulatory parties (e.g. UKAS, MHRA and BSI) supporting the Services through inspections, reportable incidents and consultations. Ensuring 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 gleamed from Incidents and Feedback received; ensure Service and Product requirements are reflective of the changes needed.
Know and understand the meaning behind our virtues and leadership behaviours and embody them in all aspects of your role.
Qualifications
We are seeking strong experience and/or qualifications gained in:
software engineering and digital service development, ideally within a software house or business
an understanding of engineering controls and metrics, familiarity with industry standards such as IEC 62304
genomics.
Additional Information
Closing date for applications: Thursday 25th September at 11.59pm
Salary from: £51,000
Being an integral part of such a meaningful mission is extremely rewarding in itself, but in order to support our people, we’re continually improving our benefits package. We pride ourselves on investing in our people and supporting them to achieve their career goals, as well as offering a benefits package including:
Generous Leave: 30 days’ holiday plus bank holidays, additional leave for long service, and the option to apply for up to 30 days of remote working abroad annually (approval required).
Family-Friendly: Blended working arrangements, flexible working, enhanced maternity, paternity and shared parental leave benefits.
Pension & Financial: Defined contribution pension (Genomics England double-matches up to 10%, however you can contribute more if you wish), Life Assurance (3x salary), and a Give As You Earn scheme.
Learning & Development: Individual learning budgets, support for training and certifications, and reimbursement for one annual professional subscription (approval required).
Recognition & Rewards: Employee recognition programme and referral scheme.
Health & Wellbeing: Subsidised gym membership, a free Headspace account, and access to an Employee Assistance Programme, eye tests, flu jabs.Equal opportunities and our commitment to a diverse and inclusive workplace
Genomics England is actively committed to providing and supporting an inclusive environment that promotes equity, diversity and inclusion best practice both within our community and in any other area where we have influence. We are proud of our diverse community where everyone can come to work and feel welcomed and treated with respect regardless of any disability, ethnicity, gender, gender identity, religion, sexual orientation, or social background.
Genomics England’s policies of non-discrimination and equity and will be applied fairly to all people, regardless of age, disability, gender identity or reassignment, marital or civil partnership status, being pregnant or recently becoming a parent, race, religion or beliefs, sex or sexual orientation, length of service, whether full or part-time or employed under a permanent or a fixed-term contract or any other relevant factor.
Genomics England does not tolerate any form of discrimination, harassment, victimisation or bullying at work. Such behaviour is contrary to
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