Director Manufacturing Labeling and Packaging

Purpose and Scope The Director Manufacturing – Labeling and Packaging provides end-to-end leadership and accountability for commercial labeling, visual inspection, device assembly, secondary packaging, and cartoning operations within Windsor Manufacturing. The role is responsible for safe, compliant, reliable, and efficient execution across a portfolio of products, technologies, and shifts, with accountability for schedule delivery, product quality, equipment performance, workforce capability, cost, and continuous improvement. The Director leads through managers and frontline leaders and partners closely with Quality, Engineering, Maintenance, Automation, MS&T, Validation, Supply Chain, Regulatory, and other functions to strengthen process control, resolve issues, deploy sustainable technical solutions, and prepare the organization for future demand and technology. Essential Duties & Responsibilities Operational Leadership Provide strategic and day-to-day leadership for labeling, visual inspection, assembly, tray-pack, and cartoning operations across assigned Windsor manufacturing areas. Own execution of the production schedule, aligning labor, equipment, materials, training, maintenance, and cross-functional support to meet business and patient-supply commitments. Establish consistent operating standards and performance-management routines across shifts, including tiered accountability, escalation, shift handoffs, leader floor presence, and effective use of controlled digital or visual-management systems. Monitor and improve safety, quality, schedule adherence, OEE, throughput, yield, cycle time, right-first-time, labor productivity, deviation, and equipment-reliability performance. Ensure labeling and packaging operations are inspection-ready and executed in accordance with approved procedures, product and component specifications, serialization requirements, in-process controls, and applicable regulatory commitments. Maintain clear ownership and timely escalation of constraints involving staffing, components, artwork, recipes, vision systems, inspection, equipment, or quality disposition that could affect schedule or supply. Compliance & Regulatory Maintain a strong quality and compliance culture and ensure alignment with cGMP, data integrity, safety, labeling control, serialization, traceability, and applicable regulatory requirements. Provide Manufacturing leadership for deviations, investigations, risk assessments, change controls, and CAPA, emphasizing rapid containment, scientifically sound root cause, and sustainable engineering or system controls. Partner with Quality and Regulatory functions to ensure batch records, label and packaging documentation, recipes, electronic records, and quality-system actions are accurate, controlled, timely, and inspection-ready. Ensure operational tools, tier systems, job aids, and performance records have clear governance and do not create uncontrolled or parallel quality records. Represent Manufacturing during health authority inspections, customer audits, and internal governance reviews for labeling, inspection, packaging, and related quality-system matters. Packaging Technology, Reliability & Process Support Partner with Engineering, Maintenance, Automation, MS&T, Validation, Quality, and suppliers to improve equipment condition, process capability, inspection effectiveness, and line reliability. Provide business ownership for labeling and packaging technologies, which may include vision and inspection systems, printers and coding, serialization, labelers, assembly equipment, thermoforming, cartoning, case packing, and material-handling systems. Support equipment qualification, validation, technology transfer, product launches, artwork or component changes, recipe changes, and implementation of new processes and technologies. Build sustainable autonomous-maintenance, troubleshooting, centerlining, standard-work, changeover, and equipment-care practices in partnership with te…

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