Hays Specialist Recruitment • City of London, London EC2V 6DN

GCP QA Consultant (Contract)

About this role

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

As a GxP QA Consultant (GCP led), you will play a key role in shaping and delivering the organisation's quality framework, with a primary focus on GCP but with exposure across broader GxP disciplines (GLP / GMP depending on pipeline and scope).

Key responsibilities will include

  • 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

This is a high-impact role, working closely with senior leadership in a growing biotech environment.

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.