Your new company

You will be supporting an innovative UK-based biotech entering first-in-human studies, backed by strong funding and progressing a novel therapeutic pipeline into early clinical development. The organisation is at a pivotal stage, building out its clinical and quality infrastructure as it transitions toward the clinic.

Your new role

• Supporting the development and streamlining of GCP SOPs
• Providing QA oversight of CROs and clinical vendors
• Conducting and supporting GCP audits (internal/vendor/study-level)
• Driving inspection readiness (MHRA/FDA/EMA)
• Advising on phase appropriate QMS build without overengineering

What you'll need to succeed

• Proven experience within GCP QA in biotech or pharma environments
• Strong background supporting early clinical / FIH studies
• Experience building or improving QMS frameworks and SOPs
• Hands-on experience with audits and vendor oversight
• Ability to work autonomously in a fast-paced, evolving environment

What you'll get in return

• Opportunity to support a biotech at a critical inflection point
• Exposure to end-to-end QMS build and FIH readiness
• Flexible, high-autonomy contract environment
• Competitive Rate

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.