Manager of Non-Conformance - Root Cause Analysis/Deviations
Core
Lead the site's deviation and non-conformance management program, driving rigorous root cause analysis (RCA) and corrective/preventive action (CAPA) to ensure compliance and quality in a radiopharmaceutical manufacturing environment.
Role type
Manager, Quality Assurance (Non-Conformance/CAPA)
Builds
Inspection-ready quality systems, data-driven compliance dashboards, and a high-performing team of investigators.
Domain
Biopharmaceuticals / Radiopharmaceuticals / Quality Assurance
Required skills
Root cause analysis (RCA), CAPA management, FDA/EMA regulatory compliance, Lean methodology, team leadership, audit support, data analytics, GMP documentation
Preferred skills
Biologics manufacturing, Cell and Gene Therapy, Radiopharmaceuticals, aseptic fill/finish, advanced degree (MS/MBA)
Technologies
eQMS, 5-Why, Fishbone, FTA, FMEA, ARCA, VSM, SPC
Responsibilities
Lead deep-dive investigations for high-risk deviations, define and improve RCA frameworks, manage the full NC/CAPA lifecycle, coach and develop a team of investigators, prepare for regulatory audits, and present quality metrics to leadership.
Seniority
Manager, direct people management