Senior Quality Compliance Auditor Clinical Trials
Fortrea —Leeds
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Senior Quality Compliance Auditor Clinical Trials

Fortrea -
Leeds

Apply Now

Job details

Full-time

Qualifications

Biology
Non-conformance investigation
Clinical research
Internal quality management system auditing
Corrective and preventive actions (CAPA)
Compliance audits
Quality management
Master's degree
Bachelor's degree
Continuous improvement
Clinical audit participation
Clinical audit
Clinical compliance monitoring
Good Clinical Practice (GCP)
Root cause analysis
Internal quality assurance
Good Clinical Practice (ICH-GCP) guidelines

Full job description

What if your Quality and Compliance expertise helps a new medicine take its first step in humans?

Fortrea is one of the largest and longest‑established early‑stage clinical research organizations in the world.

We operate four Phase I clinical research units globally, including our world‑class Leeds clinic. Just a 7‑minute walk from the train station, it is one of the few MHRA‑accredited Phase I units in the UK.

If Fortrea´s Leeds Phase I unit is where life‑saving medicines begin their journey, this job exists to help our teams to continuously raise the bar. As our next Senior Compliance Auditor , you will provide embedded Quality and Compliance support , working closely with a variety of teams during live clinical research activity. You will bring audit expertise and practical Quality insight directly into the day‑to‑day running of studies.

This is a full‑time , permanent job, based on site at Fortrea’s Leeds Drapers Yard Clinical Research Unit.

In this role you will

Through collaboration, audit expertise, and strong relationships, you will help ensure the unit consistently operates to the high standards expected of an MHRA‑accredited Phase I environment.

Support and host sponsor and client audits , planning and coordinating audits end to end, working closely with site SMEs to ensure the clinic is well prepared and professionally represented.
Lead internal audits across the Leeds Phase I unit, reviewing clinical, pharmacy, laboratory, and screening processes to identify opportunities for improvement and strengthen ways of working.
Work in partnership with Unit´s teams during live clinical research activity , providing practical Quality and Compliance input where it adds most value.
Manage Quality events , including deviations , investigations , and CAPAs , supporting teams to understand root causes and implement effective, sustainable actions.
International collaboration across Fortrea´s Quality Global Phase I network, to share audit findings, compare approaches, and contribute to the design of continuous improvement initiatives and standardised practices.

What success looks like in practice

Success in this role is reflected in trust and visibility.

You are operating independently as a trusted Quality partner on site, confidently leading audits end to end and knowing when and how to engage the right people. You are a visible presence during critical moments, spotting issues early and supporting teams to resolve them before they escalate.

Through strong working relationships and sound judgement, you contribute directly to keeping the site inspection ready, accredited, and trusted by sponsors.

Qualifications

A Bachelor’s degree in a Pharmacy, Chemistry, or Biology related discipline.
Preferred: a postgraduate degree (MSc or equivalent) in a science or management‑related discipline.

This role may be appointed at Senior or non‑Senior level, depending on experience.

At Senior level , you bring extensive Quality and Compliance experience from a GCP‑regulated clinical trials environment , such as a CRO or hospital research setting, with a solid understanding of clinical research regulations.
At non‑Senior level , we will also consider candidates with a strong Quality background from other GxP‑regulated environments (pharmaceutical, GMP, or GLP.)
You bring experience managing Quality events , including deviations, investigations, and CAPAs, and take a practical, solutions‑focused approach to continuous improvement.
Experience working with a Quality Management System (QMS) is expected. Experience with Veeva Vault is an advantage but not essential, as training will be provided.
Experience in Phase I clinical research is welcome but not required.

Skills

Across all levels, you demonstrate:

Self‑assurance to engage with sponsors, challenge issues constructively, and represent the clinic during audits and inspections
Autonomous delivery , owning audits and Quality activities end to end
Strong relationship building , working effectively across QA, clinic teams and SMEs.

Why this role is different

For us, Quality doesn’t happen at a desk .

You´ll work embedded on site, supporting teams during live Phase I clinical research, not reviewing issues after the fact.

High trust, high autonomy.

You´ll use judgement and experience to shape how the clinic operates day to day.

Global perspective, local impact.

From Leeds, you´ll have global reach collaborating with colleagues across Fortrea’s global Phase I Quality network.

If you’re ready to be the Quality partner teams rely on, not the auditor they avoid later, apply now

Learn more about our EEO & Accommodations request here .

Apply Now

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