Manager - QA Investigation and CAPA
Core
Oversee and approve quality investigations, CAPAs, and effectiveness checks for cell therapy manufacturing processes 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 writing, data analysis, team leadership, process improvement
Preferred skills
Experience in deviation management, knowledge of 5-WHY/Fishbone analysis, ability to coach staff, strategic thinking
Technologies
MS Office, Smartsheets, electronic databases, root cause analysis tools
Responsibilities
Review and approve complex investigations and CAPAs, author technical reports on deviations, coach employees on deviation processes, resolve investigational issues, liaise with global teams, support internal/external audits, drive continuous improvement projects
Seniority
Manager, people management and IC capability