Supervisor, Quality Operations
Core
Lead frontline quality execution across aseptic manufacturing, ensuring compliant, timely, and risk-based decisions to protect product quality and patient safety.
Role type
Supervisor, Quality Operations (503A/503B Compounding Pharmacy)
Builds
Compliant pharmaceutical products for distribution to patients nationwide
Domain
Healthcare / Pharmaceutical Manufacturing (503A/503B)
Deliverable
production ML models | product features
Required skills
cGMP regulations, aseptic manufacturing, batch record review, deviation management, CAPA governance, change control, risk-based decision-making, team leadership, cross-functional collaboration, process optimization, inspection readiness
Preferred skills
AI tool proficiency, data analytics, predictive analytics, knowledge management tools
Technologies
AI-enabled review tools, electronic documentation platforms, data analytics tools, AI-supported collaboration tools
Responsibilities
Lead daily review and disposition of batch records; Direct investigations for deviations and quality events; Oversee lot disposition and release workflows; Supervise CAPA processes from initiation to effectiveness verification; Review and approve quality-related changes; Maintain oversight of cGMP adherence and quality system effectiveness; Lead, coach, and develop quality professionals; Partner with Manufacturing, Validation, Engineering, Laboratory, and Regulatory teams; Identify opportunities to improve workflows and eliminate inefficiencies; Drive proactive risk identification and mitigation; Ensure continuous preparedness for regulatory inspections
Seniority
Supervisor, hands-on IC with team leadership
