Virology Quality Manager (ID4629)

Do you want to be part of a team safeguarding standards of animal and plant health and welfare? If so, why not join us and make a difference.

The Animal and Plant Health Agency (APHA) is an executive agency of the Department for Environment, Food & Rural Affairs, and works on behalf of the Scottish Government and Welsh Government. Our diverse teams of over 3,000 skilled and committed professionals come together to provide research, advice and support to UK Government for safeguarding animal, public and plant health for benefit of the environment and economy.

APHA is a brilliant place to work where our people feel valued, have a voice and can be their authentic selves. We value difference and diversity, because it helps us be more innovative and make better decisions. We are dedicated to being an inclusive employer, offering equitable opportunities for all individuals. Our goal is to build a diverse workforce, and we hope to attract applications from all backgrounds and underrepresented groups.

The Science Directorate (SD) delivers high quality, high impact and highly relevant multidisciplinary science. Our People are diverse, talented, engaged and inspired to deliver innovative outcomes.

The Virology department is a multi-disciplinary team with a statutory remit in named reportable, endemic, notifiable and exotic diseases for the delivery of research, diagnostic services and surveillance programmes. As the Quality Manager in the Virology department, you will ensure that the department continues to meet ISO9001:2015 certification, ISO/IEC17025:2017 accreditation requirements and GxP (Good Practice) compliance through performing audits, investigating non-conforming work and providing quality training for staff.

Main areas of work will include:

• Ensure all Virology quality system processes under ISO:9001, ISO:17025 quality standards, GxP compliance and the DEFRA Joint Codes of Practice for Research (JCoPR) for research areas are adhered to locally.
• Providing the lead in all 3rd party quality audits e.g. UKAS (UK Accreditation Service) / Bureau Veritas. Assist in organising and hosting external audits, providing support to teams in preparing for external assessments and preparing responses.
• Assist in maintenance, review and improvements to the Quality Management System (QMS) to ensure on-going compliance with external auditors.
• Ensure audits are planned and conducted following QMS procedures and completed according to specified deadlines.
• As a trained auditor, perform, report and effectively close out actions for all Virology quality system auditing including test witness, vertical, directed auditing and additions to ISO17025:2017 scope of accreditation. Train others in Virology to perform these audits and ensure an annual schedule of audits is planned each year with expected dates and names of auditors. Carry out Quality induction training for new starters and refresher training as required.
• Support Quality Liaison Officers and staff within the department by sharing expertise, giving clear concise guidance and advice to promote best practice and the application of the QMS.
• Manage investigations as a result of non-conforming work (NCW), deviations and complaints following the QMS. Train all staff in effective root cause analysis and ensure effectiveness reviews are completed.
• Review and monitor action progress from audits and non-conformances raised, ensuring implemented actions are appropriate, effective and implemented within documented deadlines. To escalate all outstanding actions with the Head of Department (HoD), according to agency procedure.
• Review test turnaround times from LIMS and investigate any anomalies with test manager, and complete non-conformance as required.
• Oversee external quality assurance (EQA) schemes within the Virology Department and where appropriate raise NCW and conduct trend analysis.
• Performing the annual quality system review for the Virology Management Team.
• Providing assurance that the department is implementing the quality systems appropriately, identifying concerns and promoting best proactive within the team. Identifying areas of non-compliance via own and others audits. As Local Quality Manager (LQM) spend time within the specialist areas working with scientific staff, observing activities and rectifying errors/poor practice when observed.
• Editing and publishing Virology Standard Operating Procedures (SOPs) on Content Cloud+ ensuring the established document control systems are adhered to.
• Oversee the management of the equipment database and where appropriate, flag equipment that needs replacement.
• Represent Virology on relevant Science Directorate QM groups, e.g. Science Directorate Quality Management Committee (SDQMC).
• Prepare high level quality briefing to senior management at Virology Management Meetings (VMT) as providing more in depth briefing at Quality focussed VMTs.
• Chair and minute the Virology Quality Management Team meetings every 6 weeks.
• Provision of training and advice to Virology staff for in house equipment performance management procedures to maintain accreditation.
• Identify opportunities for efficiency gains and continual improvement through appropriate harmonisation of methods and procedures across the department.
• To fulfil responsibilities for Health and Safety as defined in the APHA Health and Safety Policy and appropriate standards, Risk Assessments and SOPs. Ensure any Health and Safety issues identified during Quality audits are raised. Maintain a safe and productive working environment.
• Line management of Deputy Quality Manager.

You will need to demonstrate the following:

• Knowledge and experience of working to quality standards, particularly ISO17025:2017, ISO9001:2015 and GxP (Good Practice)
• Understanding of laboratory techniques molecular and serology techniques 
• Good written and communication skills 
• Computer literacy with Microsoft Office, SharePoint Online and database software
• BSc in Science or equivalent experience.

Security clearance

The Weybridge site is a strategically important national asset due to its role as a reference laboratory supporting the Governments response to national emergencies including disease outbreaks. For this reason all postholders based on the APHA Weybridge site must hold a valid Counter Terrorist Check (CTC) security clearance or above. It is up to each person applying for a post at APHA Weybridge to ensure they meet the residency criteria. Applicants must be currently resident in the UK & have at least three years continuous UK residency as this is a requirement to work at the Weybridge site where the team and work is situated.

Ways of Working

The agreed amount of time spent at a workplace for this post will reflect the requirement for Civil Servants to spend at least 60% of their working time in an organisation workplace with the option to work the remaining time flexibly from home. Working time spent at a workplace may include time spent at other organisational locations for meetings for example. Travel costs to non-contractual workplaces will be subject to departmental travel and subsistence policies. Travel costs to contractual workplaces are the responsibility of the employee.

Periodic travel within the UK and Europe may be required to attend training courses, conferences and scientific meetings.

Out of hours work may be required. When overtime or out-of-hours work is required, APHA Management reserves the right to change overtime patterns to meet requirements. You may be eligible for overtime payments and where overtime is approved you will receive appropriate payment.

A valid full driving licence is necessary or access to an alternative means of transport.

The post holder must work from the location listed in the Location section of the advert.

The successful candidate will need to comply with a number of health protocols and wear protective clothing and Respiratory Personal Protective Equipment (RPPE) as required. A level of physical fitness is required to be able to access biosecure areas due to the need to access the buildings and requirement to wear personal protective equipment which in some laboratories requires a full change of clothes.

The post will also require Health clearance. Depending on the areas of work involved you will be expected to have any necessary vaccinations or health surveillance including Influenza A Viruses, Rabies Group 3, skin Sensitizers and Tetanus. This will be arranged by the Health Team, Weybridge. It may also be necessary to undergo a pre-employment medical assessment.