Job Description
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 overengineeringThis is a high-impact role, working closely with s...
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 overengineeringThis is a high-impact role, working closely with s...