GCP Auditor

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Assist in the quality management system, which includes SOPs, training, and CAPA.

• Process and oversee documentation for controlled documents.

• Design and implement training for employees and/or consultants.

• Conduct client/sponsor audits and support regulatory inspections.

• Organize and execute assessments of potential vendors, including vendor audits.

• Perform internal audits of quality systems.

• Carry out investigator site audits.

• Execute trial master file audits.

• Engage in computer systems validation projects.

• Provide QA consultation and support to designated project teams.

• Oversee reported quality issues and manage associated corrective and preventive actions.

• Monitor quality systems to offer feedback on compliance risks and pinpoint areas for improvement.

⛳️ Requirements

• Extensive experience in managing audits within a clinical trials environment.

• Solid understanding of GCP/ICH guidelines and FDA regulations.

• Bachelor’s degree in a science, healthcare, or related field.

• Willingness to travel up to 25% domestically and/or internationally.

• A minimum of 2 years’ experience in a QA GCP department in a related industry is preferred.

• QA certification is preferred (e.g., CQA, SQA, etc.).

• Familiarity with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.).

🏝️ Benefits

• Contribute to the development of the quality management system.

• Participate in training sessions.

• Opportunity to work from home.

• Access to roles in high-impact clinical trial areas.