Service Quality Partner - software focus (we have office locations in Cambridge, Leeds & London)

• 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) 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 31 July at 11.59pm

Salary from: 51000

Being an integral part of such a meaningful mission is extremely rewarding in itself but in order to support our people were 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 Englands 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 toour virtues undermines our mission and core values and diminishes the dignity respect and integrity of all parties.  Our People policies outline our commitment to inclusivity. 

We aim to remove barriers in our recruitment processes and to be flexible with our interview processes. Should you require any adjustments that may help you to fully participate in the recruitment process we encourage you to discuss this with us. 

Blended working model

Genomics England operates a blended working model as we know our people appreciate the flexibility that hybrid working can bring. We expect most people to come into the office a minimum of 2 times each month. However this will vary according to role and will be agreed with your team leader. There is no expectation that people will return to the office full time unless they want to however some of our roles require full time on site attendance e.g. lab teams reception team. 

Our teams and squads have and will continue to reflect on what works best for them to work together successfully and have the freedom to design working patterns to suit beyond the minimum. Our office locations are: Canary Wharf Cambridge and Leeds.

Onboarding background checks

As part of our recruitment process all successful candidates are subject to a Standard Disclosure and Barring Service (DBS) check.  We therefore require applicants to disclose any previous offences at point of application as some unspent convictions may mean we are unable to proceed with your application due to the nature of our work in healthcare.