Senior Manager GD GCP Auditing (UK)
Core
Lead risk-based quality auditing activities to strengthen GCP compliance for global development clinical studies.
Role type
Senior Manager, GCP Auditing
Builds
Global development quality assurance processes and compliance frameworks
Domain
Clinical Research / Pharmaceutical Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GCP audit leadership, risk-based audit program development, FDA/EU/ICH regulation interpretation, process and site audit execution, regulatory inspection support, complex compliance issue management, stakeholder partnership building
Preferred skills
Master's degree, advanced project management, negotiation
Technologies
GxP compliance frameworks, audit management tools
Responsibilities
Lead end-to-end GCP audits across internal and external activities, schedule and conduct routine and directed audits, develop and execute risk-based audit programs, identify compliance issues and drive process improvements, represent Quality Assurance on complex compliance projects, support regulatory inspections
Seniority
Senior Manager, strategic leadership with hands-on execution
