CAPA Leader, Regional Quality PDx
Hybrid
Core
Lead the effective closure of CAPA/Deviation/Change Control records and drive high-quality QMS outcomes across the PDx network.
Role type
Senior Quality Systems Manager (CAPA)
Builds
Robust quality decisions and regulatory compliance for patient safety
Domain
Medical Devices / Pharmaceuticals
Deliverable
dashboards & analysis
Required skills
CAPA management, project management, Lean methodologies, root-cause analysis, statistical analysis, audit readiness, cross-functional collaboration
Preferred skills
TWD system expertise, GMP QMS knowledge, change management, coaching
Technologies
TWD system
Responsibilities
Manage execution of QMS records, lead CAPA Review Boards, own site trending and data analysis, ensure audit readiness, coach and develop team members
Seniority
Senior, hands-on IC with leadership
