Manager, Quality Assurance

Job description

Description: The Manager, QA – Kentucky Distribution Center is responsible for overall Quality Assurance leadership and oversight of all quality systems, regulatory compliance activities, and quality operations within the Kentucky Distribution Center and Transportation operations. This position ensures that all distribution-related activities, including product receipt, inspection, storage, release, returns, recalls, transportation, environmental controls, and compliance programs, are performed in full compliance with cGMPs, FDA regulations, company Quality Manual requirements, and applicable regulatory standards. The role provides strategic direction, quality system governance, audit readiness leadership, and people management for the QA Distribution team. Essential Functions: - Quality System Oversight & Governance: Provides full QA oversight for distribution center operations, including product receipt, inspection, storage, handling, release, customer returns, recalls, HOLD/QUARANTINE inventory, and transportation quality. - Ensures all distribution quality systems are compliant with FDA regulations, cGMPs, and corporate quality standards. - Owns and maintains distribution cente...