About this role
Job summary
This is an exciting opportunity to join a well-established team delivering gold standard research within the Wessex Research Hubs which is part of a national initiative known as the Commercial Research Delivery Centre (CRDC) to become a Senior Quality Assurance (QA) Lead. You will be at the heart of the QA process to ensure alignment across all hubs and use your experience & expertise to guide junior members of the team. This role is fast paced, forward thinking and adaptable to the right candidate.
Main duties of the job
1. Maintain systems to ensure that all research studies delivered within the research hubs are conducted in accordance with 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 MHRA Guidance on GCP for CTIMP laboratories, the Human Tissue Act, the Health and Safety Executive, Gene Therapy Advisory Committee (GTAC) 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.
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
About us
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.
Job description Job responsibilities
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 monitoring 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.
Person Specification
Qualifications Essential
Masters degree or equivalent professional knowledge underpinned by formal relevant qualifications. Current certificate in ICH GCP (International Conference on Harmonisation Good Clinical Practice) R3 Experience of undertaking, co-ordinating or managing clinical research, either from an NHS, academic or commercial setting. Evidence of relevant continual professional development. Experience of managing phase I, II and III clinical trials (all or some). QA Management experience. Experience of implementing new systems and processes in a quality / research environment. Experience providing training.
Desirable
Clinical /Laboratory qualification or training or equivalent experience. Evidence of continual professional development within a management role. Project Planning and management experience. Experience of leading re-design or change management initiatives.
Qualities and Attributes Essential
Good inter-personal skills must be able to influence and motivate others in order to achieve results. Able to analyse highly complex information and make appropriate judgements. Methodical with good organisational skills with attention to detail. Good time management skills able to plan and work to agreed timescales and to multi-task effectively. Evidence of ability to motivate others. Ability to listen to others and use critical questioning of techniques. Ability to prioritise and quickly identify the main core issues in a situation. Ability to use problem solving skills. Able to demonstrate behaviours that meet the Trust Values Evidence of creativity, resourcefulness and tenacity.
Desirable
Experience of influencing senior academic/clinical members of staff.
Experience Essential
Proven ability to maintain highly complex information sources and databases. Excellent IT skills, including MS Office, internet and various databases. Up to date knowledge of major regulatory issues governing the conduct of clinical research. Experience of and/or trained in conducting root causes analyses and the Patient Safety Incident Response Framework. Good understanding of confidentiality issues. Must be able to collaborate with multiple teams from differing professional backgrounds Ability to work under pressure and maintain high quality work. Knowledge of the inspection and regulation environment in which the Trust operates. Sound knowledge of the Research, Clinical, Information and Corporate Governance agendas
Desirable
Experience of regulatory inspections
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.
Employer details Employer name The Adam Practice
Address NIHR Wessex CRDC
University Hospitals Southampton
Tremona Road
Southampton
Hampshire
SO16 6YD
United Kingdom
Employer's website https://www.adampractice.co.uk/ (Opens in a new tab)