Quality Assurance Manager

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Detailed job description and main responsibilities

General
• Contribute to policy development for NUH.
• The post holder must ensure GCP and R&I SOP training is complete and their training records are up to date.
• Maintain precise and accurate quality management records that are ready for inspection by regulatory bodies and Sponsors on demand.
• Undertake quality assurance checks of research activity undertaken within and behalf of NUH, in conduction with our partners, including but not limited to our suppliers, BRC Partners, the CRF and Clinical Trials Unit.
• Support the management and monitoring of systems to document accountability and traceability of Investigational Medicinal Products (IMPs)/study drugs in order to make certain that their receipt, storage, dispensing, administration and disposal is undertaken in accordance with local SOPs.
• Recognise and respond to research governance and quality issues that might arise during quality assurance checks.
• Recognise and act upon departures from legislative and research governance requirements including failure to follow protocols and/or SOPs, responding appropriately and escalating as required.
• Promote a quality culture among NUH and our partners researchers.
• Liaise with members of medical and non-medical staff regarding research quality assurance issues where appropriate. Maintain good working relationships with academic and service departments in order to promote effective teamwork.
• Recording and reporting adverse events/adverse reactions to the R&I board and the wider research teams when appropriate, ensuring that staff involved with incidents provide all necessary reports, submissions and notifications to the attention of R&I and regulatory authorities.
• Work autonomously and efficiently on the quality assurance audit programme.
• Maintain effective communication on quality assurance systems across NUH where non compliances have been identified through audit or inspection.
• Ensure that any Trust reporting system, including Datix, are utilised appropriately when required and if reported safety learning reports relate to protocol deviations, appropriate follow-up action is taken.
• Meet with the Research and Innovation Head of research Governance, Quality and Integrity (GRGQI) on a regular basis to provide feedback on workload and audit progress.
• Organise and chair regular QA operational meetings e.g. Audit & CAPAs, Training performance.
• Work in accordance with Trustwide policies and procedures.
• Liaise with NUH departments to ensure the facilitation of the transition to electronic patient records.
• Assist in any information governance or potential fraud and misconduct issues identified through audit or inspection.
• Attend QA/GCP HRA/MHRA conferences and training forums.

Education and Training
• Maintain a high level of knowledge relating to the EU and UK legislation, regulations, management and conduct of research and act as an NUH expert on these matters.
• Provide support and advice to NUH researchers regarding ICH-GCP and compliance.
• Assist the HRGQI in preparing and delivering targeted training programmes of ICH-GCP, research governance, compliance and quality management to departments involved in research and pharmacovigilance activities, and other members of the Research and Innovation department.

Documentation Management
• Overall Management of the R&I GCP documentation e.g. policies, SOPs and forms.
• Manage the preparation, review and approval of policies, standard operating procedures and forms, ensuring that all regulatory and Trust requirements are encapsulated.
• Manage the documentation control of SOPs and forms.
• Manage the biennial review process for SOPs.
• Ensure SOPs and forms are published in the correct format and location.

CAPA Management
• Overall Management of the R&I CAPA system i.e. tracker and documentation.
• Meet with CAPA owners on regular basis to ensure timelines are feasible.
• Provide metrics on CAPAs to the HRGQI for quarterly reporting.

Training Management
• Overall Management of the R&I Training system including the R&I Induction and annual GCP Safety Training programme.
• Issue SOP training to R&I staff and researchers, follow up on training completeness.
• Provide metrics on training completeness to the HRGQI for quarterly reporting.

Vendor Management
• Overall Management of the R&I Approved Vendor system.
• Issue vendor questionnaires and follow up on completeness.
• Provide metrics on Training completeness to the HRGQI for quarterly reporting.

Audits and Inspections
• Provide input into the development of the audit strategy and quality assurance function.
• Maintain and deliver the audit programme for the research and pharmacovigilance functions within NUH to determine on-going compliance to ICH-GCP, regulatory requirements, research protocols and NUH SOPs and policies.
• Interact with research teams, departments and vendors in order to perform:

- Investigator site audits,

- Vendor audits,

- Pharmacovigilance audits,

- Process audits,

- Documentation audits.
• Ensure the audit programme is annually reviewed with the HRC and is risk based. Work with the HRC to determine vendor audit requirements and ensure vendor audits are scheduled as part of the annual audit programme (where required).
• Maintain robust systems to protect the rights of research participants, acting to prevent the disclosure of sponsors' proprietary information or subjects 'identity except to authorised individuals e.g. external audits
• Liaise with research teams to ensure audit responses and findings are complete.
• Ensure all audit findings are relayed to the HRGQI so that any corrective and preventive actions can be put in place where necessary.
• Ensure that these audit activities are documented and that findings are disseminated within NUH in order to drive continuous improvement to procedures.
• Ensure all overdue audits are escalated to research team, HRCQI and senior R&I management (where required).
• Support preparation for and facilitating external audits carried out by Sponsors and regulatory bodies.
• Assist in providing responses to audit/inspection findings and coordinating corrective and preventative actions.
• Assist in the preparation of complex reports for the Clinical Effectiveness Committee documenting audit activities, metrics, findings and resolutions.

Person specification

Essential

Essential criteria

• Must be able to demonstrate behaviours consistent with the Trust's behavioural standards
• Educated to at least Master's level / or equivalent preferably in a related subject area, e.g. a life science or clinical subject.
• Professional knowledge of clinical research acquired through a degree, and supplemented by: i. suitable clinical trial coordination; or ii. management within a relevant organisation.
• Expert knowledge of: i. Good Clinical Practice as defined in the Medicines for Human Use (Clinical Trials) Regulations; ii. the Human Tissue Act and iii. the Mental Capacity Act.
• Knowledge of principles governing confidentiality and security of personal data.
• Evidence of Continuous Personal Development
• Working with trial managers, researchers, academic supervisors and department managers.
• Knowledge of the clinical trial lifecycle, including set-up and management of quality assurance activities within a clinical research environment.
• Within in either a pharmaceutical company, contract research organisation, NHS or academic setting conducting and reporting of GCP audits of: i. participating investigator sites; ii. vendors (selection and management); iii. pharmacovigilance; iv. processes; and v. documentation.
• Developing, implementing and following standard operating procedures, with an emphasis on quality assurance procedures, in a clinical research environment.
• Delivering quality assurance and research-related training modules to a variety of audiences.
• Knowledge of medical, scientific and /or research terminology.
• Proficient IT skills, particularly in the use of Web applications and MS Office applications.
• Proven interpersonal skills to work with clinical and management colleagues at all levels across a range of organisations.
• Ability to communicate difficult and sometimes challenging information both orally and in writing, both internally to colleagues and externally to a range of audiences.
• Ability to build excellent working relationships and gain the respect and confidence of others.
• Highly motivated, with the ability to influence and inspire others.
• Ability to provide leadership in the management of change.
• Ability to analyse and interpret research management information.
• Ability to make judgements regarding a range of highly complex research management issues.
• Strong problem solving and negotiation skills.
• Ability to plan, manage and deliver complex projects, involving multiple agencies and individuals and a range of tasks.
• Ability to manage time effectively, prioritise work and to deliver results consistently to tight timelines.
• Ability to work with minimal day-to-day supervision.
• Ability to prepare and deliver presentations and reports to a high standard.
• Flexible approach to working and a desire to develop knowledge.
• Attention to detail.
• Physical effort: Frequent requirement to work in a restricted position, when using a computer.
• Mental effort: Frequent requirement for concentration, with an unpredictable work pattern
• Emotional effort: Occasional exposure to distressing or emotional circumstances, or challenging behaviour.
• Working conditions: Use of computer continuously for prolonged periods on most days.
• Ability to travel across both campuses, regionally and nationally to conduct audits and attend meetings, training and conferences.

Desirable criteria

Desirable criteria

• Understanding of other GCP principles and clinical investigations of medical devices (ISO14155).
• Understanding of the UK Policy Framework for Health and Social Care Research (2017).
• Working within the NHS research governance framework.
• Set-up and management of a risk-based annual quality assurance program.
• QA systems management within research or pharmaceuticals/ medical devices.
• Conducting audits to defined metrics, including implementation of contingency planning, risk analysis and innovative strategies.
• Knowledge of current national systems and structures for the approval, management and monitoring of clinical research in the NHS.
• Experience of research across a range of therapeutic areas.
• Project management experience in a leadership capacity.
• Experience of regulatory inspections.
• Full driving licence and access to a vehicle for business use.

Come and join our wonderful team at NUH. We are big believers in diversity and welcome new ideas to help develop our team in order to deliver world class healthcare to the vast patient populations we serve. With endless personal development opportunities available, at the NUH we will endeavour to turn your job into a career!

We particularly welcome applications from people who identify as Black, Asian and Minority Ethnic, or Disabled, as we are striving to be better represented at NUH.

Closing Dates: Please submit your application form as soon as possible to avoid disappointment; we reserve the right to close vacancies prior to the published closing date if we receive a sufficient number of completed application forms.

Communication: All communication related to your application will be via the email address you have provided. Please ensure you check your email account including your junk email regularly.

Easy read application: if you have a disability and find it difficult to complete our online application form, you can apply via our easy read application which you can find on the intranet https://www.nuh.nhs.uk/easy-read-job-application

NUH are now able to offer application completion support and interview preparation support. Please follow the link to book onto our sessions: Support for NUH Job Applications

If you are aged 16 or 17 and applying for a role that is more than 20 hours a week, please be aware that you will be asked to commence an Apprenticeship within the Trust alongside your role, as long as there is a suitable apprenticeship standard available. This is in line with the current guidance in England that whilst young people under the age of 18 can leave school (on the last Friday in June) they must then do one of the following:

• Stay in full-time education, for example at a college
• Start an Apprenticeship
• Spend 20 hours of more a week working or volunteering, while in part-time education or training

For more details visit; School leaving age - GOV.UK (www.gov.uk)

Salary: The quoted salary will be on a pro rata basis for part time workers.

Disability Confidence: All applicants who have declared a disability and who meet the essential criteria for the post will be shortlisted.

At Risk of redundancy: NHS employees within the East Midlands who are 'at risk' of redundancy will be given a preferential interview where they meet the essential criteria of the person specification.

International Recruitment: If you are applying for a role with us from outside of the UK then please read the guidance on applying for a health or social care job in the UK from abroad.

ID and Right to work checks: NUH authenticate ID and right to work documentation including passports and driving licenses through a system called Trust ID. NUH will scan your ID and right to work documentation in to the Trust ID system at your face to face ID appointment. The system will run a check against the key security features within your documentation. The system will provide us with an outcome of your check which will be stored securely on your personal file along with all other pre-employment check documentation.

Consent:

• Transfer of information: If I have previous NHS service - I consent to the transfer of my Electronic Staff Record (ESR) data between this and other NHS Trusts. I also consent to the Occupational Health Department confidentially accessing my occupational health records from my current or previous employer in order to check the status of my vaccinations, immunisations s and screening tests as relevant to the post. I understand this is an automated process and the information will only be used for these purposes prior to me taking up the position at NUH.
• Disclosure and Barring Service: Your post maybe subject to a DBS check which incur a cost dependent on the level of check required (£42.90 for enhanced and £22.90 for standard). I agree to reimburse Nottingham University Hospitals NHS Trust the cost of a Disclosure and Barring Service (DBS) check if it is required (by deduction from first month's pay). Should I decide to withdraw from my job offer, I agree to reimburse Nottingham University Hospitals NHS Trust the cost of the DBS check undertaken by cheque or other agreed method.
• For more information about our organisation and the career opportunities available, please visit our website and/or follow us on Instagram, Twitter and Facebook

Employer certification / accreditation badges

Documents to download

• Quality Assurance Manager (PDF, 720.3KB)
• Quality Assurance Manager (PDF, 320.6KB)
• Mindful Employer (PDF, 242.5KB)
• Equality and Diversity (PDF, 122.3KB)
• Equal Opportunities (PDF, 57.4KB)
• Disability Confidence Scheme (PDF, 51.0KB)
• Rehabilitation of Ex Offenders (PDF, 106.0KB)