Director of Quality (we have office locations in Cambridge, Leeds & London) at Genomics England

Leeds, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

15 May, 26

Salary

105500.0

Posted On

14 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Strategy Development, Quality Culture, Continuous Improvement, Quality Governance, ISO 15189, ISO 13485, UK Medical Device Regulations, UKCA Marking, Software Quality, Software as a Medical Device (SaMD), SDLC Management, Risk Management, Data Analysis, Regulatory Compliance, Team Leadership, Systems Thinking

Industry

Biotechnology Research

Description

Company Description Genomics England is a global leader in enabling genomic medicine and research, focused on creating a world where everyone benefits from genomic healthcare. Building on the 100,000 Genomes Project, we support the NHS’s world-first national whole genome sequencing service and run the growing National Genomic Research Library, alongside delivering numerous major genomics initiatives. By connecting research and clinical care at national scale, we enable immediate healthcare benefits and advances for the future. Our mission is to provide the evidence and digital systems so that by 2035 genomics could play a role in up to half of all healthcare interactions, whilst securing the UK’s position as the best place to discover, prove and benefit from genomic innovations. 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. Behind the Healthcare and Research outcomes, Genomics England delivers through designing, developing and operating complex healthcare software systems. We're on the cusp of big changes with the real prospect of genomics becoming the fabric of everyday healthcare through the lifetime – from birth to old age. Job Description We are seeking a Director of Quality to lead and champion our quality and regulatory agenda across the organisation. This role is responsible for developing and delivering Genomics England’s Quality Strategy, fostering a strong quality culture, and driving continuous improvement in how we work. The successful candidate will lead the Quality team in partnership with colleagues to ensure our clinical and software systems and processes are safe, compliant, and of the highest standard, with quality embedded in innovative research projects. You will oversee quality governance activities, including ISO audits and the maintenance of our Quality Management System (QMS). The role also includes producing and presenting clear data insights and metrics to support informed decision-making and organisational excellence. Everyday responsibilities include: Shape and deliver Genomics England’s Quality Strategy, creating a clear and achievable roadmap that supports our long-term vision. Lead and nurture an inclusive, high-performing Quality team, ensuring colleagues feel supported, empowered and able to thrive. Partner with Directors and Service Owners to embed quality into everyday clinical services, software development, research and operational delivery. Ensure ongoing compliance with ISO 15189, ISO 13485, UK Medical Device Regulations and UKCA marking, proactively preparing for regulatory change. Champion continuous improvement across medical device software, key processes (including SDLC) and healthcare services, encouraging collaboration and shared learning. Act as the senior advisor on quality to the Executive Leadership Team, ensuring systems and processes are compliant and clearly reflected in the QMS. Strengthen quality governance, including audits, Management Review, risk management and Approved/Notified Body inspections. Work closely with clinical, research and NHS partners to ensure innovative programmes can safely and effectively scale from research into clinical delivery. Oversee the maintenance and continuous enhancement of the Quality Management System (QMS), ensuring clarity, accessibility and best practice. Use data and meaningful insights to monitor performance, highlight risks, and enable transparent, confident decision-making across the organisation. Skills and experience for success: Proven experience leading Quality Operations at a senior level, with hands-on expertise in audits and maintaining strong regulatory compliance. Skilled at shaping and delivering quality strategy, balancing big picture thinking with practical actions to meet current and future organisational needs. Strong background in software quality, ideally Software as a Medical Device (SaMD), with a clear understanding of regulatory requirements and lifecycle management. Inclusive and empowering leadership style, with a track record of supporting, mentoring, and developing high-performing teams. Excellent systems thinking, able to navigate complex organisational structures, interconnected processes, data pipelines, and medical device ecosystems. Experience embedding quality into software development lifecycles and digital product delivery, promoting safe, compliant, and user-focused outcomes. Desirable skills: Knowledge of genomics, life sciences, or healthcare is a plus, while experience in these areas is welcome, we value diverse backgrounds and are open to candidates from other industries who bring fresh perspectives and transferable skills. Qualifications Technical or business degree/professional certifications in Quality. Additional Information Salary from: £105,500 Please provide a cover letter explaining how your skills and experience align with this role and its requirements. Closing date for applications - Monday 9th March 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 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. Culture We have four key behaviours that represent what we would like Genomics England to feel like and the culture we want to encourage, in order for us to achieve our mission. These behaviours help us all work well together, deliver on our outcomes, celebrate our successes and share feedback with each other. You can read about these and other aspects of our culture here Culture | Genomics England 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. Department: Quality, Improvement and Regulations Office: Leeds

Responsibilities

This role is responsible for developing and delivering the organization's Quality Strategy, fostering a strong quality culture, and leading the Quality team to ensure clinical and software systems are safe and compliant. Key duties include overseeing quality governance, managing the Quality Management System (QMS), and advising the Executive Leadership Team on quality matters.