Quality Assurance (QA) Lead in Poole

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 members of the team.

This role is fast paced, forward thinking and adaptable to the right candidate.

Please note, extensive clinical research quality assurance experience is essential for this role, We are a CQC Outstanding-rated Practice with 40,000 patients and 17 current Partners working across 5 sites.

We successfully combine efficiencies of scale with localised continuity and high quality care on individual surgery sites, whilst using a total triage appointment system to ensure acute patients are seen in a timely manner.

We have the benefit of nearly 40 years of experience as a large multi-site Practice, providing a secure and stable environment to work in., 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.

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.

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