Director, Quality Risk Management
Core
Enterprise Quality leader defining and governing global Quality Risk Management strategy, standards, and processes to ensure regulatory compliance and operational excellence across the pharmaceutical organization.
Role type
Director, Quality Risk Management (Enterprise Strategy & Governance)
Builds
Global QRM framework, standards, policies, training programs, and risk assessment portfolios.
Domain
Pharmaceutical Quality System (PQS), cGMP, ICH, GxP, Global Regulatory Compliance
Required skills
Global strategy definition, Risk-based thinking, Process design & governance, Stakeholder engagement, Change management, Data analytics (KPIs/Dashboards), Cross-functional leadership, Regulatory knowledge (cGMP/ICH)
Preferred skills
Business Process Management, Lean/Six Sigma, GxP IT systems oversight, Large-scale transformation leadership
Technologies
GVault Risk Module, Electronic QRM systems
Responsibilities
Define and execute global QRM framework and standards; Drive organizational risk maturity and culture; Oversee enterprise Quality Risk Register; Lead global network of Risk Leads and practitioners; Collaborate with Medical Device and Combination Product teams; Monitor audit outcomes and regulatory trends; Define and monitor QRM metrics and KPIs.
Seniority
Director, Senior leader of expert teams
