Senior GCP QA Lead for CRO & Clinical Research

Fusion Group; England; On-site; GBP 60,000 - 90,000; Full time

Job summary

Fusion Group Global is seeking a Quality Assurance Manager to lead QA across its CRO and Clinical Research Facility businesses, reporting to the Head of Quality. This broad, hands-on role will shape QA strategy and take ownership from trial set-up to close-out.

You will own the QMS, drive audits, oversee regulatory inspections, and ensure inspection readiness while collaborating with CRO and CRF teams to deliver CAPAs and drive continuous improvement.

Qualifications

• Experience in a CRO or CRF environment is essential.
• In-depth knowledge of GCP and UK regulations for clinical trials.
• Ability to lead quality initiatives across multiple stakeholders.

Responsibilities

• Own and develop the QMS, including SOPs, forms and templates for GCP compliance.
• Provide QA oversight across GCP, GDPR, HSE and regulatory changes.
• Deliver internal audits and manage vendor and system assessments.
• Lead regulatory inspections and sponsor audits, ensuring inspection readiness.
• Manage quality incidents, CAPAs and escalation pathways.
• Represent QA on CRO and CRF project teams during protocol review and site setup.
• Develop and deliver GCP and quality training.
• Use quality data to drive continuous improvement and strategic planning.

Skills

Leadership

GCP knowledge

Regulatory communication

Tools

QMS system

Job description

Fusion Group Global is seeking a Quality Assurance Manager to lead QA across its CRO and Clinical Research Facility businesses, reporting to the Head of Quality. This broad, hands-on role will shape QA strategy and take ownership from trial set-up to close-out.

You will own the QMS, drive audits, oversee regulatory inspections, and ensure inspection readiness while collaborating with CRO and CRF teams to deliver CAPAs and drive continuous improvement.