Investigations Supervisor

Responsibilities

• Support Area Manager and work with investigators to ensure timely completion of investigations
• Assign investigations to team members and track progress to completion
• Follow up on investigation status, corrections, CPAs, and effectiveness checks
• Perform investigations and train new investigators
• Collaborate with teams to determine if corrective actions address root causes of non-conformance events
• Support tracking of deviations, events, and key process parameters
• Identify and implement process improvements related to safety, quality, compliance, and productivity
• Serve as Subject Matter Expert (SME) during internal and external regulatory audits (FDA, EMEA)
• Review and approve SOP and Batch record revisions

Requirements

• Bachelor’s degree in Engineering, Science, or a related field
• 3 years of experience as a Lead Engineer
• Proficiency operating eLIMS, TrackWise, Maximo, EMS, BMS, and SAP systems

About the Company

Legend Biotech is a global biotechnology company dedicated to treating and curing life-threatening diseases through advanced cell therapies, including CAR-T and NK cell-based immunotherapies.