Manager - QA Investigation and CAPA
Core
Overseeing quality investigations, CAPAs, and effectiveness checks for cell therapy manufacturing to ensure regulatory compliance and product quality.
Role type
Manager, Quality Assurance (QA) Investigations
Builds
Quality assurance of manufactured cell therapy products
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Required skills
Root cause analysis, CAPA management, regulatory compliance (FDA/EMA), risk assessment, technical report authoring, cross-functional leadership, data analysis, process improvement, coaching/mentoring
Preferred skills
Experience in deviation management, knowledge of 5-WHY/Fishbone analysis, familiarity with electronic systems/databases, strategic thinking
Technologies
MS Office, Smartsheets, electronic databases, root cause analysis tools (5-WHY, Ishikawa, Process Flow Diagram)
Responsibilities
Review and approve complex investigations/CAPAs/effectiveness checks; Author and review technical reports and risk assessments; Coach employees on deviation processes; Resolve investigational process issues; Liaise with global teams; Support internal/external audits; Drive continuous improvement projects; Supervise personnel approving investigations
Seniority
Manager, people management and technical oversight