CAPA Leader
Core
Lead the effective closure of CAPA/Deviation/Change Control records across sites/departments in the PDx network using project management and Lean methodologies.
Role type
Senior Quality Management System (QMS) Leader
Builds
Robust quality decisions and regulatory compliance outcomes
Domain
Medical Devices / Regulated Manufacturing
Required skills
Project management, Lean methodologies, Root-cause analysis, Statistical analysis, Cross-functional collaboration, Audit readiness, Change management
Preferred skills
TWD system experience, GMP QMS knowledge, Coaching/mentoring
Technologies
TWD system
Responsibilities
Ensure QMS areas are analyzed and evaluated for input to records; Manage execution of QMS records; Lead CAPA Review Boards; Own site trending and data analysis; Lead others to find creative solutions to complex problems; Ensure site audit readiness; Coach and develop others.
Seniority
Senior, hands-on IC
