CAPA Leader
Core
Lead the Quality Management System by owning CAPA, deviation management, change control, and investigations to drive continuous improvement and compliance in a highly regulated environment.
Role type
Senior Quality Leader (CAPA Lead)
Builds
Quality Management System performance, investigation excellence, and sustainable process improvements
Domain
Pharmaceutical/Radiopharmaceutical / Quality Assurance & Compliance
Deliverable
dashboards & analysis
Required skills
CAPA management, deviation management, root cause analysis, change control, quality metrics, regulatory compliance, cross-functional governance, continuous improvement, risk identification
Preferred skills
GxP environment experience, industry forum participation, coaching, change leadership
Technologies
Quality Management Systems (QMS)
Responsibilities
Own and strengthen processes for CAPA, deviations, change control, and investigations; Drive investigation excellence and recurrence prevention; Provide independent monitoring of process performance; Develop KPIs and trending insights for risk identification; Lead continuous improvement initiatives; Support inspection readiness and audit activities; Partner with senior leaders on QMS performance and compliance.
Seniority
Senior, hands-on IC
