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