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 regulatory compliance and product quality.
Role type
Manager of Quality Systems (Non-Conformance & Root Cause Analysis)
Builds
A robust, inspection-ready deviation management lifecycle and a culture of continuous improvement in a radiopharmaceutical manufacturing site.
Domain
Biopharmaceuticals / Oncology / Radiopharmaceuticals / Quality Systems
Required skills
Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA), FDA/EMA regulatory compliance, Lean Six Sigma, Data Analytics, Team Leadership, Audit Management, GMP documentation, Quality Systems Management
Preferred skills
AI-enabled quality tools, Electronic Quality Management Systems (eQMS), Statistical Process Control (SPC), Human Factors Analysis
Technologies
5-Why, Fishbone Diagrams, Fault Tree Analysis (FTA), FMEA, Apollo Root Cause Analysis (ARCA), Value Stream Mapping (VSM), PDCA, Kaizen, SPC, Poka-Yoke, eQMS
Responsibilities
Define and improve the site's RCA framework using structured tools; lead deep-dive investigations for high-risk non-conformances; oversee the full deviation lifecycle from initiation to closure; champion data analytics and AI capabilities for quality trends; drive Lean methodologies to reduce investigation cycle time; build and train a team of investigators; ensure inspection readiness for FDA/EMA audits.
Seniority
Manager, hands-on IC with team leadership
