Michael Page
Crestwood, IL
Quality Operations LeadershipDirect day-to-day Quality Operations activities supporting manufacturing and laboratory operations. Ensure timely review and disposition of batch records, CAPAs / Deviations / Investigations, change controls, validations, product impact assessments. Lead batch disposition and product release decisions in accordance with established quality standards and regulatory requirements. Drive quality oversight on the manufacturing floor through active engagement and visible leadership. Establish robust metrics and dashboards to monitor product quality, process performance, compliance, and operational effectiveness.FDA Compliance & Inspection ReadinessEnsure compliance with 21 CFR Parts 820, 210 and 211, FDA Guidance Documents, USP and compendial requirements, ISO 13485 and ISO 14971, where applicable. Maintain a state of continuous inspection readiness across manufacturing, laboratories, warehouses, and quality systems. Lead site preparation and hosting...