Associate Director, Global Quality Risk Management
Core
Lead the design, implementation, and standardization of enterprise Quality Risk Management (QRM) capabilities aligned with ICH Q9 to embed risk-based thinking into the Quality Management System (QMS) and operational decision-making.
Role type
Associate Director, Global Quality Risk Management
Builds
Enterprise QRM framework, global risk standards, methodologies, tools, and templates
Domain
Biotechnology / Pharmaceutical Quality Systems (GxP)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ICH Q9 framework implementation, GMP and Quality process integration, risk assessment techniques, health authority inspection preparation, global training program deployment, cross-functional partnership
Preferred skills
Advanced degree (MS/PhD), mentoring and coaching experience, cultural change leadership
Technologies
ICH Q9, QMS, GMP
Responsibilities
Lead development of enterprise QRM framework, define global risk standards and methodologies, embed risk principles into deviation management and change control, prepare materials for health authority inspections, lead ICH Q9 training programs, partner with governance forums
Seniority
Management, strategic leadership