Director, Clinical Risk Management Post Approval Delivery Unit

Tasks

• Advise on research quality and compliance
• Assess serious quality issues
• Coach and mentor inspection readiness teams
• Coordinate quality integration for asset or company acquisitions
• Coordinate risk identification assessment mitigation
• Develop CAPA plans and effectiveness checks
• Develop and support quality agreements
• Develop risk mitigation plans
• Ensure inspection readiness
• Lead inspection processes and inspection tools
• Lead quality risk monitoring reviews
• Manage quality investigations and escalations
• Oversee quality risk management
• Provide guidance on quality risk assessments
• Provide investigational site inspection support
• Provide sponsor monitor inspection support
• Support asset divestment
• Support third party inspection readiness

Perks/Benefits

• Career development
• Inclusive work environment
• Mentorship and coaching
• Up to 10 percent travel

Skills/Tech-stack

CAPA | Clinical Practice | Clinical risk management | Clinical trials | Compliance Management | Compliance Risk | Corrective and Preventive Action | Data Visualization | Data analytics | Effectiveness Checks | GCP | Good Clinical Practice | ICH Guidelines | Inspection Readiness | Management System | Microsoft Office | Operating procedures | Preventive Action | Project Management | Project Planning | Qms | Quality Agreements | Quality Control | Quality Management System | Quality management | Quality risk assessment | Regulatory Compliance | Risk Assessment | Risk Management | Risk Mitigation | S&OP | Spotfire | Standard Operating Procedures | Tableau