Senior Manager, Quality Systems
Core
Lead Quality and Compliance functions for dietary supplement manufacturing, overseeing operational quality, testing, and release while ensuring regulatory compliance.
Role type
Senior Manager, Quality Systems (Manufacturing)
Builds
High-quality gummy delivery formats for nutritional supplements and nutraceuticals
Domain
Pharmaceutical and dietary supplement manufacturing
Required skills
Quality Assurance, Compliance, Root Cause Analysis, Change Control, Audit Management, Risk Mitigation, Training Program Development, KPI Tracking, Sanitation Monitoring, Regulatory Communication
Preferred skills
Investigation Writing, Electronic Systems (JDE, TrackWise, Veeva), FDA Inspection Handling, AI Tools for Quality
Technologies
JDE, TrackWise, Electronic Document Management System, Learning Management System, Quality Management System, Veeva, Compliance Wire, Stability Programs
Responsibilities
Oversee Quality and Compliance functions; Lead a team of QA Supervisors and Specialists; Review and approve change controls and deviations; Ensure compliance with FDA, NSF, and SQF requirements; Develop and maintain quality policies; Identify and mitigate product quality risks; Lead the Food Safety Team; Monitor facility sanitary state; Collaborate with Operations on sanitation programs; Maintain feedback loop with Customer Service; Oversee training programs; Establish and track KPIs; Collaborate with cross-functional teams; Drive continuous improvement; Communicate with regulatory agencies; Oversee investigations and environmental monitoring; Support site management in enforcing GMPs.
Seniority
Senior, hands-on IC with management responsibilities
