Quality Assurance (QA) Lead

Maintain

systems to ensure that all research studies delivered within the research hubs

are conducted in accordance with all applicable UK legislation and guidance

including the UK's UK Policy Framework for Health & Social Care Research,

The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, the

UK's Medical Devices Regulations (2002 and amendments), the International

Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP), the

Human Tissue Act, and, where applicable, regulations from European and

international competent authorities such as the US Food and Drug Administration

(FDA).

2.

Develop (in conjunction with the QA/Governance working group) and implement a

quality management system for regional research hub studies and monitor systems

to ensure regulatory compliance throughout the research study lifecycle,

developing quality procedures to support study initiation, study

implementation, study close down and study archiving.

3.

Act as a principal contact for regulatory agencies during mandatory inspections

of research hub studies, accompanying the inspectors, liaison with the CRDC

Wessex QA and Governance Group Chair(s), R&D QA Manager, Principal

Investigator(s) and responding promptly to requests for information and

ensuring that designated staff are available for interview as required. As well

as ensuring reports are completed within expected timeframes and appropriate

corrective actions and preventative action plans are in place.

To

develop, implement and maintain systems to assure the quality of clinical

research undertaken within the Wessex research hubs and busses in accordance

with a variety of regulatory Statutes, guidelines and protocols. To develop and

deliver local quality verifying and auditing programmes and coordinate

preparations for external sponsor audit and regulatory inspection by the

Medicines and Healthcare Products Regulatory Agency (MHRA) and other regulatory

agencies. To be responsible for Governance and Quality Assurance (QA)

initiatives linked to the research programs to ensure that there is a

consistent quality standard for clinical trial work undertaken in the hubs.

This work to be carried out in collaboration with R&D QA Manager, regional

QA/governance working group and individuals working within QA roles in the

research hubs.

CRDC

Wessex Host Organisation

University

Hospital Southampton is one of England's largest acute teaching Trusts,

offering a wide range of learning and development opportunities to support your

career aspirations.

Located

on the south coast with an international airport and direct rail links to

London, Southampton offers an ideal setting to live and work, with the New

Forest, South Downs and Jurassic Coast.

At

UHS, were committed to providing a flexible working environment where possible.

Whether you are balancing family, study, or your wellbeing with your career, we

want to support you so you can help our patients.

At

UHS, we proudly champion individuality, recognising that outstanding care is

only possible with a diverse, inclusive team. Were committed to creating an

anti-racist, anti-discriminatory environment where everyone feels valued, safe,

and empowered to make a meaningful impact in our communities. We welcome

applicants of all backgrounds, identities, and experiences to join us in

building a healthcare community where everyone can belong, thrive, and

contribute.

Qualifications

Experience

Qualities and Attributes