Associate Director, Global Quality Risk Management
Core
Lead the design, implementation, and standardization of enterprise Quality Risk Management (QRM) capabilities aligned with ICH Q9 and global regulatory expectations.
Role type
Senior management Quality Risk Management lead
Builds
Enterprise QRM framework, global risk standards, methodologies, and governance processes
Domain
Biotechnology / Pharmaceutical Quality Systems
Required skills
ICH Q9 framework implementation, GMP and Quality system leadership, risk assessment techniques, health authority inspection preparation, global training and mentoring, cross-functional partnership
Preferred skills
Advanced degree (MS/PhD), experience leading QRM and QMS process integration
Technologies
ICH Q9, QMS, GxP
Responsibilities
Lead development of enterprise QRM framework; Define and maintain global risk standards and tools; Embed risk-based principles into core QMS processes; Partner with process owners to define risk thresholds; Lead enterprise ICH Q9 training and coaching; Prepare materials for health authority inspections and audits; Monitor evolving external expectations for QRM.
Seniority
Director level, strategic leadership with hands-on execution
