Quality Assurance Lead (Clinical Trials)

Perspectum Ltd; Oxford; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading company in the pharmaceutical solutions sector seeks a Quality Assurance Lead to enhance and manage the quality function for its Pharma Solutions business unit. This role offers the opportunity to lead quality assurance in clinical trials while ensuring compliance with global regulatory standards and fostering a quality-focused culture within the team.

Qualifications

• Extensive experience in pharma, biotech, or CRO quality assurance roles.
• Strong knowledge of GDPR, GCP, and clinical trial regulatory frameworks.
• Experience with CAPA strategies and leading audits.

Responsibilities

• Develop and oversee a comprehensive QMS that meets global pharma regulatory standards.
• Lead audits, regulatory inspections, and supplier evaluations.
• Promote a proactive culture of quality in client projects.

Skills

Problem-solving

Risk management

Analytical skills

Leadership

Stakeholder management

Education

Certified Lead Auditor

Job description

Are you a Clinical Trial Quality Assurance expert looking for an opportunity to lead and shape a function while staying hands-on?

We’re looking for a Quality Assurance Lead to manage, and continuously improve the Quality function for our Pharma Solutions business unit. If you have experience in clinical trials and a passion for ensuring quality at every step of the process, this is your opportunity to make an impact while remaining hands-on.

This role is perfect for someone who thrives in an individual contributor leadership position—meaning you’ll have the autonomy to own and drive the QA function while working closely with cross-functional teams to ensure compliance, operational excellence, and a strong quality culture.

About the Role:

• Develop and oversee a comprehensive QMS that meets global pharma regulatory standards.
• Lead audits, regulatory inspections, supplier evaluations, and vendor quality assessments—collaborating with wider compliance teams.
• Maintain compliance oversight with FDA, MHRA, EMA, and ICH guidelines with a particular focus on clinical trial regulations.
• Own the CAPA process, ensuring timely and effective resolution of quality issues.
• Act as a key strategic partner, aligning pharma quality objectives with business goals.
• Support quality planning for new projects and ensure scalable, sustainable systems.
• Represent the company in client audits, inspections, and regulatory interactions.
• Promote a proactive culture of quality and provide expert QA input on client projects and clinical trial operations.

About You:

• Extensive experience in pharma, biotech, or CRO quality assurance roles with a focus on clinical trial quality assurance.
• Strong knowledge of GDPR, GCP, and clinical trial regulatory frameworks (ideally for an imaging CRO).
• Certified Lead Auditor with a track record of leading audits and implementing CAPA strategies.
• Strong problem-solving, risk management, and analytical skills.
• Ability to work autonomously while engaging with cross-functional teams.
• Exceptional communication, leadership, and stakeholder management abilities.
• Experience in budget management (ideally), project oversight, and process improvements.

About Us:

At Perspectum, we are committed to fostering diversity, equity, and inclusion. We prioritize hiring based on merit, skills, and qualifications, valuing individuals for their unique contributions while ensuring a culture that respects and celebrates differences. If you require any reasonable adjustments as part of your application process, please let our Talent Team know.