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

Fortrea is one of the largest and longestestablished earlystage clinical research organizations in the world.

We operate four Phase I clinical research units globally including our worldclass Leeds clinic. Just a 7minute walk from the train station it is one of the few MHRAaccredited Phase I units in the UK.

If Fortreas Leeds Phase I unit is where lifesaving 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 daytoday running of studies.

This is a fulltime permanent job based on site at Fortreas 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 MHRAaccredited 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 Units 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 Fortreas 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 Bachelors degree in a Pharmacy Chemistry or Biology related discipline.
• Preferred: a postgraduate degree (MSc or equivalent) in a science or managementrelated discipline.

This role may be appointed at Senior or nonSenior level depending on experience.

• At Senior level you bring extensive Quality and Compliance experience from a GCPregulated clinical trials environment such as a CRO or hospital research setting with a solid understanding of clinical research regulations.
• At nonSenior level we will also consider candidates with a strong Quality background from other GxPregulated environments (pharmaceutical GMP or GLP.)
• You bring experience managing Quality events including deviations investigations and CAPAs and take a practical solutionsfocused 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:

• Selfassurance 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 doesnt happen at a desk.

Youll work embedded on site supporting teams during live Phase I clinical research not reviewing issues after the fact.

High trust high autonomy.

Youll use judgement and experience to shape how the clinic operates day to day.

Global perspective local impact.

From Leeds youll have global reach collaborating with colleagues across Fortreas global Phase I Quality network.

If youre ready to be the Quality partner teams rely on not the auditor they avoid later apply now

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