Visual Inspection Associate Program Manager
Core
Lead the visual inspection program for liquid and lyophilized injectable products, ensuring regulatory compliance and driving continuous improvement in fill/finish operations.
Role type
Associate Manager, Visual Inspection Program
Builds
Visual inspection program strategy, defect libraries, and operator/equipment qualification processes
Domain
Biopharmaceutical manufacturing (fill/finish)
Required skills
cGMP/GDP compliance, visual inspection program management, regulatory standards (USP <1790>, EU Annex 1, 21 CFR Part 211), team leadership, KPI monitoring, cross-functional collaboration, equipment qualification, defect classification
Preferred skills
Automated/AI/ML-based inspection technology evaluation, ownership of visual inspection program elements
Technologies
KNAPP, test sets, AI/ML-based detection systems
Responsibilities
Lead the Visual Inspection Technical Services team and Defect Creation Lab; Own site visual inspection program strategy and standards; Ensure processes meet regulatory guidance; Drive development of defect libraries and qualification tools; Monitor program KPIs for continuous improvement; Partner cross-functionally on inspection processes; Manage and develop team members
Seniority
Associate Manager, hands-on leadership