Director, Clinical Risk Management Post Approval Delivery Unit

Tasks

• Coach teams on risk monitoring and mitigation
• Coordinate risk communications to business partners
• Coordinate risk identification assessment and mitigation
• Develop inspection narratives and prepare sites for inspection
• Drive quality risk monitoring reviews
• Ensure consistent issue interpretation for quality investigations
• Escalate significant quality issues
• Lead inspection processes and inspection tools
• Maintain inspection readiness
• Oversee quality risk management for clinical trials
• Provide CAPA plan and effectiveness check guidance
• Provide strategic guidance on quality risk assessments
• Support sponsor monitor inspections

Perks/Benefits

• Inclusive work environment
• Travel up to 10 percent

Skills/Tech-stack

CAPA | Clinical quality | Clinical risk management | Clinical trials | Compliance Management | Data Visualization | Data analytics | GCP | ICH Guidelines | Inspection Readiness | Microsoft Office | Quality Management System | Quality management | Quality management system (QMS) | Quality risk assessment | Risk Assessment | Risk Management | Risk monitoring | S&OP