Senior Quality and Compliance Specialist (GCP & CRO Experience)

Location: Home-based in the United Kingdom; London listed as the role location. Travel up to 30% within the UK and EU is required for audits.

Company

hirify.global is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data and regulatory submission challenges.

What you will do

• Plan, prepare, and conduct GCP audits independently.
• Author and manage audit documentation.
• Develop CAPA plans and contribute to resolving audit findings.
• Monitor vendors and clinical investigator sites to ensure compliant processes and sustained quality.
• Support additional compliance activities within the Quality and Compliance department.

Requirements

• At least 5 years of experience in a GCP-regulated industry, such as clinical research coordination, clinical research, or GCP auditing.
• College degree in a scientific, medical, or clinical discipline, or related experience; a minimum of 7 years in a GCP-regulated industry may substitute for a degree.
• Proficiency with 21 CFR Part 11, FDA, and GxP requirements.
• Expert knowledge of scientific principles, clinical terminology, the drug development process, and CRO operations.
• Proficiency with Microsoft Office and strong organizational, communication, and problem-solving skills.

Nice to have

• Master’s degree.
• Hands-on experience with clinical trials and pharmaceutical development.

Culture & Benefits

• Home-based working arrangement in the United Kingdom.
• Opportunity to work with pharmaceutical, biotech, and medical device clients.
• Collaborative and inclusive working environment.
• Travel within the UK and EU for audits, up to 30% of the time.