Director of Quality

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.

• 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.

• 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 life cycles and digital product delivery, promoting safe, compliant, and user‑focused outcomes.

• Knowledge of genomics, life sciences, or healthcare is a plus; experience in these areas is welcome, but we value diverse backgrounds and are open to candidates from other industries who bring fresh perspectives and transferable skills.
• Technical or business degree/professional certifications in Quality.

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,…