Sr. Manager - Quality - Visual Inspection & Particulate Control
Core
Provide strategic and technical Quality leadership for manufacturing and laboratory quality systems, focusing on Visual Inspection and particulate matter control for injectable products.
Role type
Senior Manager, Quality Systems (Pharmaceutical Manufacturing)
Builds
Inspection programs, qualification/validation studies, and risk-based particulate control strategies for sterile injectable products.
Domain
Pharmaceutical manufacturing, sterile injectables, quality assurance
Required skills
Visual inspection program leadership, particulate control strategy, qualification and validation, complex investigation and root cause analysis, CAPA management, regulatory inspection response, cGMP and USP <790>/<1790> knowledge, risk assessment, matrix leadership
Preferred skills
Advanced degree in Pharmaceutical Sciences/Chemistry/Microbiology, commercial sterile manufacturing experience, particulate characterization techniques, continuous improvement (Lean Six Sigma), direct interaction with FDA/EMA/Health Canada
Technologies
USP <790>, USP <1790>, cGMP
Responsibilities
Lead Quality oversight for manual, semi-automated, and automated visual inspection programs; Develop and maintain risk-based particulate control strategies; Provide technical leadership for qualification and validation activities; Direct complex investigations involving visible particulate matter; Partner with Operations, Engineering, Laboratory, and Quality teams; Support regulatory inspections and customer audits; Establish and monitor quality performance metrics and risk indicators
Seniority
Senior, hands-on IC with people leadership