Director, Global Clinical Operations – Quality Management

Role Overview

• Strategic leadership of GCO Quality Management
• Collaborate with GCO leadership to develop and implement the strategy and direction for the GCO QM team
• Execute GCO QM mission and vision, including oversight of Global Support Centers
• Propose, lead, and implement GCO QM initiatives aligned with GCO priorities
• Provide end-to-end oversight of quality issue management including triage, severity, categorization, RCA, and closure
• Conduct trend analysis of GCO quality issues and audit findings
• Support audit and inspection preparation and execution
• Oversee planning, conduct, and reporting of site assessments

Requirements

• 15+ years’ experience in late phase clinical research
• 7-10 years’ experience managing people
• Expertise in ICH-GxPs
• English proficiency (written and oral)

Benefits

• Health insurance
• Retirement plans
• Paid time off
• Professional development
• Flexible work arrangements