Senior Manager GCP Quality
Core
Lead risk-based quality management across clinical trials for global clinical development.
Role type
Senior Manager, GCP Quality Management
Builds
Global clinical development organization quality assurance
Domain
Pharmaceutical / Clinical Trials / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
risk-based quality management, quality risk assessment, audit response management, corrective and preventive action (CAPA) management, inspection readiness, team management, process improvement, project management
Preferred skills
ICH E6 R3 knowledge, contract research organization (CRO) collaboration, executive escalation, training and presentation
Technologies
Microsoft Outlook, Word, Excel, PowerPoint
Responsibilities
Lead risk-based quality management across assigned clinical trials; Drive protocol-stage Quality Risk Assessment and Control Tracker activities; Manage quality issues, audit responses, and trend analysis; Partner with study leads and CROs on site risks; Escalate significant quality events to Executive Quality Leadership; Support inspection readiness and responses; Manage team onboarding, coaching, and performance discussions
Seniority
Senior, hands-on IC with management responsibilities
