GCP Quality Assurance Consultant. LilyLifestyle

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.

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 over engineering

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

• 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

• 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