About this role

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service (FSP) solutions.

Are you a clinical quality expert ready to make a meaningful impact in a leading pharmaceutical organisation?

One of our longstanding and highly regarded global pharmaceutical clients is seeking a Senior Clinical Quality Manager to join their Clinical Operations team on a permanent basis.

This is a hybrid role, with 3 days on-site in Luton, UK.

In this influential role, you'll drive quality and compliance across local clinical trial delivery, act as the primary point of contact for audits and inspections, and partner with cross-functional teams to ensure adherence to international and local regulatory standards (ICH-GCP, SOPs, and local regulations). You'll support the development of internal quality systems, provide expert training, and play a key role in identifying and resolving quality issues.

This is an exciting opportunity to shape clinical quality practices within a forward-thinking organisation known for innovation and excellence in drug development.

Key Responsibilities:

Advise local study teams on global and local clinical processes and compliance requirements.

Lead local quality control activities and risk-based oversight.

Own and maintain local procedural documents aligned with global SOPs and regulations.

Act as audit/inspection lead and manage associated findings and CAPAs.

Support training, quality improvements, and change management initiatives.

Collaborate closely with global/regional quality, QA, and regulatory teams.

Qualifications: 

Bachelor degree in a related discipline

At least 5 years of experience in the pharmaceutical industry, preferably in Clinical Operations/Quality Assurance

Good knowledge and understanding of ICH-GCP, study management, site management, monitoring

Excellent communication skills

Good planning, organisation and problem-solving abilities

Advance user of MS Office applications

Demonstrated ability to multitask, prioritise and complete objectives

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.