Head of Quality Improvement and Regulatory Affairs

Company Description

Genomics England successfully led the world–leading 100,000 Genomes Project, which compared and analysed individuals' genetic codes to help diagnose, treat and prevent illness.

We're now accelerating our impact, working with the NHS to further develop and embed genomic healthcare and research in Britain. Our next chapter involves 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.

Job Description

We are in the process of embedding our Quality system, following an agile transformation, and are looking to appoint a Head of Quality Improvement and Regulatory Affairs with experience in Software as a Medical Device (SAMD). This is an exciting opportunity to build upon and embed the processes and systems that have been put in place and nurture a collaborative culture of quality in our ground breaking organisation, where we're blending science and technology to enable cutting edge discoveries.

In this role you will develop and execute the quality improvement and regulatory strategy and provide the day to day leadership of the quality management function, including ensuring all key activities are appropriately managed (CAPAs, audits, electronic quality systems, Risk Assessments, etc.). You will be the authorised management representative for ISO 13485 and ensure that accreditation is maintained, alongside ISO 15189 and UKCA/CE marking as well as regulatory compliance to the relevant Medical Device Regulations. It will also be your responsibility to run the quality committee, support the Chief Scientist and attend governance meetings as well as internal conversations with other chapter leads. Also included will be leading on QMS documentation such as SOPs and quality reports, internal and external audit function and training activities for key processes. Above all, you'll work to ensure our Quality function delivers in line with our strategic aims as a business.

This could be a step up for an exceptional candidate, or a great opportunity for someone who has already embedded a quality system into a similar organisation and is looking for their next challenge.

Skills & Experience for Success

– You'll have worked in an organisation that has undergone transformation, ideally in an agile environment, and have been key in embedding a quality system and establishing new ways of working.
– You will have exceptional stakeholder management skills and emotional intelligence, skilled in navigating the complex position of a quality function in an organisation where there can be conflicting priorities.
– You will have deep knowledge of quality regulation standards and process, within software as a medical device.
– You'll have direct or indirect leadership experience of a high performing, technical team and be used to leading by example and nurturing their development.
– We're expecting that applicants have expertise in QMS, CAPA systems, Audits, SOPs, Risk Assessments & monitoring plans, data analysis, ISO 15189, ISO 13485 and Medical Device Regulations.

Qualifications

Masters in a scientific discipline or equivalent experience

Additional Information

Originally conceived as a project, Genomics England has transformed to meet the long–term opportunities created by our scientific breakthroughs in understanding the Human Genome. Being part of this journey is a reward in itself, however we're pleased to offer our colleagues a great benefits package including:

* competitive salary

* 30 days holiday

* generous pension scheme

* individual learning budgets for every colleague

* a raft of other benefits

Talk to our Talent Team and find out how a career with Genomics England will benefit you