Quality Control Manager

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Detailed job description and main responsibilities

GENERAL DUTIES

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 control checks of research activity undertaken within and on behalf of NUH, in conduction with our partners, including but not limited to our suppliers, BRC Partners, the CRF and Clinical Trials Unit.

Through monitoring, support the management 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 control 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, for example, reporting serious breaches in accordance with the Medicines for Human Use (Clinical Trials) Regulations.

Promote a quality culture among NUH and our partners researchers.

Liaise with members of medical and non-medical staff regarding research quality management issues where appropriate. Maintain good working relationships with academic and service departments in order to promote effective teamwork.

Recording and reporting incidents 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.

Maintain effective communication across NUH where non-compliances have been identified through monitoring, or inspection.

Ensure that any Trust reporting systems, including DATIX, are utilised appropriately.

Meet with the Research and Innovation Head of Research Governance, Quality and Integrity (HRGQI) on a regular basis to provide feedback on workload and quality management activities.

Organise and chair regular quality management operational meetings e.g. Monitoring visits, Training performance.

Work in accordance with Trustwide policies and procedures.

Assist in any information governance or potential fraud and misconduct issues identified through quality control activities or inspection.

Maintain knowledge of legislation and guidance governing clinical research and quality management processes, for example, through attending conferences, training courses, or through relevant networks or 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.

Maintain personal training record.

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

Identify and report incidents requiring corrective and preventative actions to the Quality Assurance Manager.

Training Management

Collaborate with the R&I Workforce Development Team to ensure an appropriate training matrix for all R&I staff.

Overall management and tracking of the R&I workforce compliance with the training matrix.

Oversight of training on policies, SOPs, templates and other appropriate documentation for R&I staff and researchers, ensuring this is appropriately documented.

Provide metrics on training completeness to the HRGQI for quarterly reporting.

Manage the process for retention of staff training records in accordance with Trust Policy.

Provide support and advice to NUH researchers regarding the principles of ICH-GCP and compliance.

Assist the HRGQI, QA Manager, Research Governance Manager and Workforce Development Team in preparing and delivering targeted training programmes of the principles 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.

Vendor Management

Overall Management of the R&I Approved Vendor system.

Risk assess vendors following review of associated due diligence documentation, including the vendor questionnaire, and activities.

Approve or reject vendors on completion of due diligence documentation and activities.

Review vendors in accordance with associated standard operating procedures.

Inspections

In collaboration with the HRGQI and senior management team, conduct the appropriate preparation for local inspections.

Provide support during the conduct of local inspections.

Assist in providing responses to inspection findings and coordinating corrective and preventative actions.

Monitoring

Develop, maintain and deliver a risk-based monitoring programme for the research and pharmacovigilance functions within NUH to determine on-going compliance to the research protocols, principles of ICH-GCP, regulatory requirements, and NUH SOPs and policies.

Review risk assessments and monitoring plans to ensure a risk proportionate approach to monitoring.

Review and define acceptable error rates, and take appropriate actions to address any failure to meet required standards.

Interact with research teams and departments to arrange monitoring activities, to include (but not limited to):

Source data verification

Consent processes

Pharmacovigilance activities

Accountability (investigational medicinal products, devices and equipment, and clinical samples)

Ensure the monitoring programme is annually reviewed and is risk based.

Liaise with research teams to ensure monitoring reports are complete, overseeing completion of any actions.

Ensure all monitoring findings are relayed to the appropriate teams, such as the Quality Assurance Manager and HRGQI so that any corrective and preventive actions can be put in place where necessary, which may include triggering audits for the QA team.

Ensure that these monitoring activities are documented and that findings are disseminated within NUH in order to drive continuous improvement to procedures.

Ensure all overdue monitoring visits are escalated to research team, HRGQI and senior R&I management (where required).

Assist in the preparation of complex reports for the relevant QC oversight committees, documenting monitoring activities, metrics, findings and resolutions.

This list of responsibilities is not exhaustive, the post holder will be expected to undertake any other relevant duties appropriate to the grading of the post.

Person specification

Commitment to Trust Values and Behaviours

Essential criteria

• Must be able to demonstrate behaviours consistent with the Trust's "We are here for you" behavioural standards

Training & Qualifications

Essential criteria

• Educated to at least Master's level / or equivalent experience 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

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).

Experience

Essential criteria

• Experience working with trial managers, researchers, academic supervisors and department managers.
• Knowledge of the clinical trial lifecycle, including set-up and management of quality control activities within a clinical research environment.
• Experience within in either a pharmaceutical company, contract research organisation, NHS or academic setting conducting and reporting of: i. risk assessments (including defining and reviewing acceptable error rates); ii. monitoring visits; iii. source data verification
• Experience developing, implementing and following standard operating procedures, with an emphasis on quality control procedures, in a clinical research environment.
• Experience delivering quality control 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.

Desirable criteria

• Experience of working within the NHS research governance framework.
• Experience of the set-up and management of a risk-based annual quality control program.
• Experience of quality systems management within research or pharmaceuticals/ medical devices.
• Experience of conducting quality control activities to defined metrics, in a risk-proportionate approach, and taking appropriate actions to address any failures to meet required standards.
• 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.

Communication and Relationship Skills

Essential criteria

• 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.

Analytical and Judgement Skills

Essential criteria

• 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.

Planning and Organisation Skills

Essential criteria

• 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 Skills

Essential criteria

• 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.

Other requirements specific to the role (e.g. be able to drive or work shifts)

Essential criteria

• Ability to travel across both campuses, regionally and nationally to conduct audits and attend meetings, training and conferences

Desirable criteria

• 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.

Applicants are kindly requested to refrain from using AI at any stage during the recruitment process.

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 online job applications difficult, you can use an easy read application form instead.

To get this form, please email nuhnt.recruitment@nhs.net and ask for an easy read 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 (£49.50 for enhanced and £21.50 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

Applicant requirements

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

Documents to download

• Quality Control Manager Job Description (PDF, 472.4KB)
• Quality Control Manager Person Specification (PDF, 280.4KB)
• 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)
• Application Process Booklet (PDF, 24.8MB)