Fusion Group
Quality Assurance (GCP) Manager
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Quality Assurance Manager | GCP | CRO & Clinical Research Facility
Fusion Group Global is partnering with an innovative clinical research organisation that runs both a CRO and its own Clinical Research Facility. They're looking for a Quality Assurance Manager to lead QA across the whole business, reporting to the Head of Quality.
This is a broad, hands-on role. You'll be the quality voice from trial set-up to close-out, and you'll help shape the strategy and priorities of a growing Quality function.
What you'll be doing:
- Owning and developing the QMS, including SOPs, forms and templates, written with functional heads to ensure GCP compliance
- Providing QA oversight across GCP, GDPR, HSE and other applicable regulations, and putting regulatory changes into practice
- Delivering the internal audit programme and carrying out vendor and system assessments
- Leading or supporting regulatory inspections and sponsor audits, and keeping the organisation inspection- and audit-ready
- Making sure quality incidents, AEs, SAEs and serious breaches are reported and escalated on time, and managing the resulting CAPAs
- Sitting on CRO and CRF project teams as the QA representative, including protocol review and new site set-up
- Developing and delivering GCP and quality training
- Using quality data and trends to drive continuous improvement and feed into strategic planning
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What you'll bring:
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- Experience in a CRO or CRF
- In-depth knowledge of clinical trial management (including CTIMPs), GCP and UK Clinical Trials regulations
- A track record of quality input to multi-centre interventional studies
- Experience managing a QMS: SOPs, non-compliance and auditing
- Experience reviewing clinical trial documentation
- Strong leadership, the ability to influence stakeholders at every level, and excellent written and verbal communication
- GCP training, plus a degree or professional qualification (or equivalent experience)
Nice to have:
- Experience hosting regulatory inspections and sponsor audits
- Experience with an electronic QMS
- An auditing certification
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