GCP QA Consultant (Contract)

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 SOPsProviding QA oversight of CROs and clinical vendorsConducting and supporting GCP audits (internal/vendor/study-level)Driving inspection readiness (MHRA/FDA/EMA)Advising on phase appropriate QMS build without overengineeringThis 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 environmentsStrong background supporting early clinical / FIH studiesExperience building or improving QMS frameworks and SOPsHands-on experience with audits and vendor oversightAbility to work autonomously in a fast-paced, evolving environmentWhat you''ll get in return Opportunity to support a biotech at a critical inflection pointExposure to end-to-end QMS build and FIH readinessFlexible, high-autonomy ..... full job details .....