Senior Scientist - Quality Lead

UK Health Security Agency; Idmiston; Hybrid; GBP 41,000 - 55,000; Full time

Job summary

A leading health security agency in the UK is seeking a Quality Lead to develop and maintain the Quality Management System for high throughput sequencing tests. Responsibilities include managing audits, ensuring compliance with ISO15189 standards, and supporting quality improvements. The ideal candidate should have experience in molecular biology, strong leadership skills, and relevant qualifications. This role offers competitive salary and flexible working arrangements.

Benefits

Defined Benefit pension scheme

Flexible working patterns

Access to retail discounts

Qualifications

• Experience of diagnostic molecular biology testing and methods.
• Experience in managing quality in an accredited laboratory.
• Experience of working in a regulated environment.

Responsibilities

• Manage and maintain the Quality Management System for diagnostic tests.
• Support the Quality Co-Ordinator and Head of Operations.
• Ensure laboratory participation in EQA surveys.

Skills

Quality management

Leadership

Molecular biology testing

ISO15189 standards

Problem solving

Education

BSc or MSc in biological discipline

Tools

Q-Pulse software

Job description

Job Overview

Supports UKHSA's genomics surveillance programmes. Aids detection of outbreaks and transmission of infections. Characterises and correlates genomics to virulence and antimicrobial resistance. Generates evidence to support effective interventions to reduce the overall public health burden.

The site is certified to ISO9001:2015. A number of laboratories are accredited to UKAS ISO15189:2022.

The Quality Lead will develop and maintain the Quality Management System (QMS) for a range of diagnostic tests primarily focused on high throughput sequencing of SARS-CoV-2 and other pathogens but could include additional molecular assays, laboratory housekeeping and maintenance, handling, recording and reporting of electronic data results, ensuring that the work is carried out to high scientific, safety and quality standard and leadership of a small team. This includes departmental responsibility for managing the electronic quality management system, Q-Pulse, which manages complex information on a variety of UKHSA and Public Health Microbiology-wide topics including documents and records, audits and non-conformities, complaints and compliments, equipment, suppliers and training records which ensure ongoing assurance of high-quality work and compliance with standards and regulations.

Candidates with HCPC registration will be appointed on NHS T&Cs at NHS AfC Band 7, candidates without will be appointed on Civil Service T&Cs at SEO grade.

Key Responsibilities

• Support the Technical Manager, National Quality Co-Ordinator, Head of Operations and Deputy Director for Pathogen Genomics in achieving, developing and maintaining the QMS, accreditation and certification, and in supporting continual improvement in quality processes in accordance with UKHSA policies and procedures.
• Focus on maintaining UKAS ISO15189 accreditation status for the COVID sequencing service and extension to scope for other pathogen genomics services as they are implemented.
• Provide professional direction and leadership in establishing an effective QMS culture within the Pathogen Genomics team at Porton Down, meeting ISO15189 requirements.
• Ensure that processes needed for the quality management system are established, implemented and maintained.
• Report directly to the Technical Manager and National Quality co-ordinator on the performance of the QMS and identify any need for improvement.
• Ensure the promotion of awareness of users' needs and requirements throughout the laboratory organisation.
• Provide quality feedback on laboratory performance with regular communications via emails, reports and presentations.
• Ensure the laboratory participates in suitable EQA surveys, monitors results and feeds back any deficiencies to Management.
• Maintain awareness of ISO15189 standard and QMS-related software, attending training as appropriate and assist in the implementation of Q-Pulse quality management software in the laboratory.

This list is not exhaustive.

Work independently to fulfil the laboratory quality related responsibilities and functions including suggesting and driving quality improvements and management of control of change procedures.

Project manage laboratory-based accreditation in liaison with accreditation bodies and undertake a lead role in the performance of gap analyses against appropriate standards.

Manage and organise the preparation for inspections by third party assessors, including UKAS, commercial organisations or research councils with whom collaborative and contract work is being undertaken. Progress quality issues arising from these inspections.

Implement and manage the laboratory audit system. This includes organisation of internal and external audit programmes, managing the corrective actions arising, planning and carrying out internal quality audits against ISO15189, ISO17025, ISO9001, and other standards in accordance with approved audit plans and report the findings.

Organise and lead the Annual Management Review. Analyse, collate and present data, including reports for discussion and assist development and implementation of quality objectives.

Produce regular quality reports to identify early warning signs of the emergence of service delivery or quality issues, or to provide the evidence to make considered informed decisions.

Develop a strategy for, and implement the measuring and monitoring of, key process and performance indicators within the laboratory.

Work collaboratively with the Technical Manager and other staff to ensure awareness of laboratory quality activities and issues in the laboratory and supervise laboratory staff performing quality assurance activities and monitor their effectiveness.

Write, edit or commission QMS-related documentation.

Contribute to the quality aspect of validation documentation to support current testing strategies and for the development of new assays.

Assist in the identification, evaluation and adaptation of new technologies and diagnostic tests to enhance the laboratories capabilities and to ensure the project area works to a high scientific standard.

Supply data to agreed timescales required by Pathogen Genomics service level agreement.

Complete training requirements as required for the post.

Ensure all work is undertaken in accordance with the UKHSA's Code of Safety Practice and to work within a Quality system acceptable with the site.

Comply with UKHSA policy and procedures.

Prioritise, co-ordinate and organise specialist investigations and supervise the team workload.

Maintain a positive attitude to the laboratory work and other members of the team.

Ensure health, safety and welfare are prioritised and to demonstrate commitment to health, safety and welfare of self, staff and visitors and comply with relevant UKHSA health and safety policies.

Escalate risks that cannot be controlled to the Technical Manager and Head of Operations.

Notify management of accidents, near misses, dangerous situations and shortcomings in health and safety.

Report any personal sickness in line with the UKHSA Sickness Absence management policy.

Participate in a joint annual review of your work.

The above is only an outline of the tasks, responsibilities and outcomes required of the role. You will perform any other duties required by the line manager commensurate with grade.

The job description and person specification may be reviewed on an ongoing basis in accordance with the changing needs of the organisation. You should maintain high professional standards by continuous professional development in accordance with any relevant professional registration or statutory requirements, keeping up to date with advances in Medical Microbiology while maintaining appropriate awareness of service provider requirements.

Selection Process

You will be required to complete an application form. You will be assessed on the listed 12 essential criteria, and this will be in the form of a:

• Application form ('Employer/ Activity history' section on the application)
• 1250 word supporting statement.

This should outline how your skills, experience, and knowledge, provide evidence of your suitability for the role, with reference to the essential criteria. The Application form and supporting statement will be marked together. Please note you will not be able to upload your CV. You must complete the application form in as much detail as possible. Please do not email us your CV.

Longlisting: In the event of a large number of applications we will longlist into 3 piles of: 1. Meets all essential criteria 2. Meets some essential criteria 3. Meets no essential criteria. Those falling into the 'Meets all essential criteria' pile will progress to shortlisting.

Shortlisting: In the event of a large number of applications we will shortlist on the following essential criteria:

• Educated to BSc or MSc level in biological discipline.

Artificial Intelligence can be a useful tool to support your application, however, all examples and statements provided must be truthful, factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others, or generated by artificial intelligence, as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see our candidate guidance for more information on appropriate and inappropriate use.

Eligibility & Nationality

This is a Non-Reserved post under the Civil Service Nationality Rules. To be eligible for employment in the UK Civil Service applicants must meet the Civil Service Nationality Rules (CSNRs) which operate independently of and additionally to the Immigration Rules. Applicants must also meet necessary security and vetting requirements, along with any other relevant pre-employment checks.

This job is broadly open to the following groups:

• UK nationals
• Nationals of the Republic of Ireland
• Nationals of Commonwealth countries who have the right to work in the UK
• Nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window)
• Nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• Individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

Pay and Benefits

Salary Bands Civil Service SEO (National) £41,983 to £48,128 per annum, pro rata NHS AfC Band 7 £47,810 to £54,710 per annum, pro rata. Candidates with HCPC registration will be appointed on NHS T&Cs at NHS AfC Band 7, candidates without HCPS registration will be appointed on Civil Service T&Cs at SEO grade. Please note: If you are successful at interview, and are moving from another government department, NHS, or Local Authority, the relevant starting salary principles for level transfers or promotions will apply. Otherwise, roles are offered at the pay scale minimum for the grade, but in exceptional circumstances there may be flexibility if you are able to demonstrate you are already in receipt of an existing, higher salary. Pay increases are through the relevant annual pay award for the role and terms.

Plus public holidays and one privilege day for the King's birthday.

Benefits include :

• Access to a generous Defined Benefit pension scheme with employer contributions.
• Access to a cycle-to-work salary sacrifice scheme, season ticket advances and payroll giving.
• Access to a retail discounts and cashback site.
• We also promote flexible working patterns (part-time, job-share, condensed hours). UKHSA views flexible working as essential in enabling us to recruit and retain talented people, ensuring that they are able to enjoy a long-lasting career with us. All employees have the right to apply for flexible working and there are a range of options available including working from home, compressed hours and job sharing.
• We also offer a generous maternity / paternity and adoption leave package.

Work Arrangement

We offer great flexible working opportunities at UKHSA and operate using a hybrid working model where business needs allow. This provides us with greater flexibility about how and where we work, to get the best from our workforce. As a hybrid worker, you will be expected to spend a minimum of 60% of your contractual working hours (approximately 3 days a week pro rata, averaged over a month). If based at one of our scientific campuses, you will be required to have a minimum of a Counter‑Terrorism Check security vetting check as a minimum. For meaningful National Security Vetting checks to be carried out individuals need to have lived in the UK for a sufficient period of time.

Essential Skills and Experience

• Educated to BSc or MSc level in biological discipline.
• Experience of diagnostic molecular biology testing and molecular methods.
• Experience in managing quality in an accredited laboratory.
• Experience in applying a range of standards, regulations and guidelines applicable to clinical laboratories such as ISO15189.
• Familiar with electronic quality management software solutions.
• Understanding of quality assurance principles and procedures.
• Relevant experience in leading teams and/or projects.
• Experience of working in a regulated environment with quality systems and knowledge of UKAS.
• Evidence of success in efficient and effective project and programme participation/management.
• Problem solving skills and ability to respond to sudden unexpected demands.
• Ability to make decisions on difficult and contentious issues where there may be a number of courses of action.
• Adaptability, flexibility and ability to cope with uncertainty and change.

Desirable Criteria

• Registration with the Health & Care Professions Council (HCPC) as Biomedical Scientist.
• Recent experience in a diagnostic or reference laboratory.
• Experience of monitoring user satisfaction and liaising with customers.
• Working knowledge of LIMS.
• Previous experience and skills in project management and planning.

Selection Process Detail

This vacancy is using Success Profiles and will assess your Behaviours, Experience and Technical skills.

• Managing a Quality Service (Lead behaviour)
• Changing and Improving
• Communicating and Influencing
• Working at Pace

You will also be asked some technical based questions during the interview. These will be based on: The principles of quality management and of service delivery in clinical laboratories.

Successful candidates must pass a disclosure and barring security check. Successful candidates must meet the security requirements before they can be appointed. The level of security needed is Counter‑terrorist Check. For meaningful National Security Vetting checks to be carried out individuals need to have lived in the UK for a sufficient period of time. You should normally have been resident in the United Kingdom for the last 3 years as the role requires Counter Terrorism Check (CTC) clearance. UK residency less than the outlined periods may not necessarily bar you from gaining national security vetting and applicants should contact the Vacancy Holder / Recruiting Manager listed in the advert for further advice.

About UKHSA

The United Kingdom Health Security Agency (UKHSA) is a system leader for health security; taking action internationally to strengthen global health security, providing trusted advice to government and the public and reducing inequalities in the way different communities experience and are impacted by infectious disease, environmental hazards, and other threats to health. UKHSA's remit, as an agency with a global-to-local reach, is to protect the health of the nation from infectious diseases and other external threats to health. As the nation's expert national health security agency UKHSA will:

• Prevent: anticipate threats to health and help build the nation's readiness, defences and health security
• Detect: use cutting edge environmental and biological surveillance to proactively detect and monitor infectious diseases and threats to health
• Analyse: use world‑class science and data analytics to assess and continually monitor threats to health, identifying how best to control and mitigate the risks
• Respond: take rapid, collaborative and effective actions nationally and locally to mitigate threats to health when they materialise
• Lead: lead strong and sustainable global, national, regional and local partnerships designed to save lives, protect the nation from public health threats and reduce inequalities.

UKHSA is investing in a new state‑of‑the‑art National Biosecurity Centre in Harlow, Essex, which will eventually bring together teams currently based at Canary Wharf, Colindale and Porton Down. For more details, please see: Huge biosecurity centre investment to boost pandemic protection – GOV.UK.

We also offer a generous maternity / paternity and adoption leave package.