Quality Assurance Manager

Job description

Job 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.

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.

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.

Please refer to the job description and person specification attached to the advert for the full details of the vacancy.

Person Specification

Physical Skills

Essential

• 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

Essential

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

Desirable

• Full driving licence and access to a vehicle for business use.

Training and Qualifications

Essential

• Educated to at least Master's level 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

• Understanding of other GxP principles and clinical investigations of medical devices (ISO14155).
• Understanding of the UK policy framework for health and social care research (2017)

Experience

Essential

• 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.
• Preparing and managing Corrective and Preventative Actions.
• Knowledge of medical, scientific and /or research terminology.
• Proficient IT skills, particularly in the use of Web applications and MS Office applications.

Desirable

• 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.

Communication and Relationship Skills

Essential

• Proven interpersonal skills to work with clinical and management colleagues at all levels across a range of organisations.
• Ability to build excellent working relationships and gain the respect and confidence of others.
• Ability to analyse and interpret research management information.
• Ability to make judgements regarding a range of highly complex research management issues.

Planning and Organisational Skills

Essential

• Attention to detail.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name

Nottingham University Hospitals NHS Trusts

Address

QMC

Nottingham

NG7 2UH

Employer's website

https://www.nuh.nhs.uk/ (Opens in a new tab)