Clinical Quality Assurance Auditor

Qualitas; Oxford; Remote; GBP 60,000; Full time

Job summary

An international QA consultancy is seeking an experienced GCP Auditor to conduct independent audits across global clinical research operations. This fully remote role offers a competitive salary of £60,000 and the opportunity to work with an established consultancy while ensuring compliance with ICH GCP regulations. Ideal candidates will have over five years of experience in GCP auditing and excellent communication skills.

Benefits

Competitive salary

Fully remote role

Professional development opportunities

Flexible working hours

Qualifications

• Minimum 5 years' experience conducting GCP audits independently.
• Proven background in QA within the pharmaceutical, biotech, or CRO environment.
• Strong understanding of ICH GCP, EU, and FDA regulations.

Responsibilities

• Plan, schedule, and conduct GCP audits.
• Prepare detailed audit reports and communicate findings effectively.
• Advise on CAPA development and follow-up to close audit findings.

Skills

GCP audit experience

QA background

Knowledge of ICH GCP regulations

Excellent communication

Time management

Ability to work autonomously

Job description

GCP Auditor - Remote

Salary: £60,000 per annum

Contract: Permanent

Location: Fully Remote (occasional travel for audits)

Sector: Quality Assurance / Clinical Research

About the Company

Our client is an international QA consultancy renowned for delivering expert GxP auditing services across the life sciences sector. Partnering with leading pharmaceutical, biotechnology, and CRO organisations, they provide trusted, independent auditing solutions across GCP, GLP, and GDP. Due to continued global growth, they are seeking an experienced GCP Auditor to join their expanding team.

The Role

As a GCP Auditor, you'll play a key role in conducting independent audits across global clinical research operations. Working remotely, you'll plan, perform, and report on approximately two audits per month, covering investigator sites, vendors, and internal systems. You'll collaborate with clients to ensure compliance with ICH GCP and applicable regulatory requirements, offering expert guidance and insight.

Key Responsibilities

• Plan, schedule, and conduct GCP audits (investigator site, vendor, system, and internal process).
• Prepare detailed audit reports and communicate findings effectively to clients.
• Advise on CAPA development and follow-up to ensure timely closure of audit findings.
• Support inspection readiness and client training initiatives as needed.
• Stay current with global GCP regulations and guidance documents.

Requirements

• Minimum 5 years' experience conducting GCP audits independently.
• Proven background in QA within the pharmaceutical, biotech, or CRO environment.
• Strong understanding of ICH GCP, EU, and FDA regulations.
• Excellent communication and reporting skills.
• Ability to manage time effectively and work autonomously in a remote setting.
• Willingness to travel internationally for scheduled audits (typically 2 per month).

What's on Offer

• Competitive £60,000 salary (plus expenses).
• Fully remote role with flexible working.
• Opportunity to work with an established international consultancy.
• Professional development and exposure to a wide range of global clients and studies.

Interested?

If you're an experienced GCP Auditor looking to join a respected international consultancy where your expertise truly adds value, we'd love to hear from you.
Apply now or contact us for a confidential discussion.