Job Title: QA Manager (Consultant) – GCP Compliance (Biotech / Phase II)
About the Company
We are a growing biotechnology company advancing Phase II clinical programs. As we expand our clinical operations and global trial footprint, we are strengthening our Quality Management System and GCP oversight. We are seeking an experienced QA Manager (Consultant) who brings strong GCP quality expertise and hands-on experience supporting teams through MHRA and FDA regulatory expectations.
This is a contract / part-time / fractional role with flexible engagement structure.
Role Overview
The QA Manager (Consultant) will lead GCP quality assurance activities across ongoing clinical trials, vendors, and documentation systems. The ideal candidate brings practical, scalable approaches to quality in a mid-stage biotech environment, and can both advise strategically and execute hands-on quality tasks.
Key Responsibilities
* Oversee and maintain GCP components of the Quality Management System (QMS) to support Phase II clinical activities.
* Perform clinical site audits, vendor/CRO audits, and internal process audits.
* Ensure ongoing GCP compliance throughout clinical trial execution.
* Serve as QA representative for inspection readiness and regulatory interactions, including MHRA and FDA expectations.
* Review and approve clinical documentation, including protocols, Investigator Brochures, monitoring plans, TMF records, deviations, and CAPAs.
* Support development and maintenance of SOPs and training programs for clinical and cross-functional teams.
* Provide coaching and guidance to Clinical Operations, Medical, and outsourced partners.
* Support preparation, response, and CAPA follow-up for inspections and audits.
Qualifications
Required
* 7+ years of Quality Assurance experience in biotechnology, pharma, or CRO environment.
* Strong GCP quality background supporting Phase I–III clinical trials.
* Demonstrated experience preparing for and supporting MHRA and FDA inspections.
* Experience conducting clinical site audits and vendor audits.
* Ability to evaluate and improve QMS processes in a growing organization.
* Excellent communication, collaboration, and documentation skills.
Preferred
* Experience with EU trials or global Quality oversight.
* Familiarity with TMF structure and metrics.
Engagement Details
* Consulting / Contract / Fractional role
* Estimated workload: 0.4 - 0.5 FTE, depending on stage and needs
* Remote or hybrid, with occasional on-site meetings or audits as required
* Contract duration: 12 months with potential extension