GCP QA Consultant (Contract)

Your newpany

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