Senior Director of Manufacturing Operations
ZRG LLC
ZRG Partners has been retained by a leading global healthcare and pharmaceutical organization to identify a Senior Director of Manufacturing Operations for a large-scale, highly regulated manufacturing operation in the Greater Chicago area. This is a senior site leadership opportunity for an accomplished pharmaceutical manufacturing executive with deep experience operating within complex cGMP environments. The Senior Director will oversee manufacturing operations to ensure products are produced safely, on schedule, within established quality standards, and against defined cost and performance objectives. Reporting to the Plant Manager, the Senior Director of Manufacturing Operations will provide leadership across multiple manufacturing departments and processes within a complex, multi-shift pharmaceutical operation. The role has responsibility for manufacturing activities spanning compounding, aseptic filling, terminal sterilization, component preparation, capping, and lyophilization. The successful candidate will lead a layered manufacturing organization, drive operational performance and continuous improvement, strengthen regulatory readiness, and ensure consistent execution against quality, safety, cost, productivity, and supply objectives. This leader will directly manage approximately seven Production Managers and/or Senior Managers and indirectly lead approximately 400 manufacturing employees and manufacturing engineers, making this a significant people and operational leadership position. Key Responsibilities Provide overall leadership for pharmaceutical manufacturing operations across multiple production areas and shifts. Establish, maintain, and continuously improve manufacturing processes and procedures for compounding, aseptic and terminal sterilization, filling, component preparation, capping, and lyophilization. Develop and execute manufacturing plans that ensure products meet established quality standards, production schedules, customer requirements, and cost objectives. Lead Production Managers and Senior Managers in achieving site manufacturing, safety, quality, and operational performance goals. Build organizational capability through hiring, development, coaching, performance management, and succession planning. Optimize workforce levels, manufacturing resources, overhead, and material utilization to achieve annual operating and budget objectives. Identify and implement opportunities to increase productivity, reduce defects, minimize scrap and rework, and improve manufacturing efficiency. Drive Right-First-Time performance, deviation reduction, and timely deviation closure to support on‑time batch release. Establish and maintain production standards and continuous improvement initiatives across manufacturing operations. Lead manufacturing programs related to training, safety, cost reduction, employee involvement, housekeeping, and operational discipline. Sponsor and coordinate major site projects, including plant layout changes, capital equipment installation, and major equipment or facility improvements. Monitor and communicate key manufacturing performance indicators, including Overall Equipment Effectiveness (OEE), production output, quality performance, and other site metrics. Serve as a manufacturing subject‑matter expert during regulatory inspections and company audits. Partner closely with Quality, Engineering, Supply Chain, Maintenance, Human Resources, and other site functions to support reliable and compliant manufacturing operations. Qualifications Bachelor's degree in a scientific, engineering, technical, or related discipline, or equivalent education and relevant experience. Required Skills The ideal candidate is an experienced pharmaceutical manufacturing executive who has led large, technically complex manufacturing organizations within a highly regulated environment. 10+ years of pharmaceutical manufacturing experience within a cGMP environment. 5+ years of progressive management experience with a broad span of organizational responsibility. Demonstrated experience leading large manufacturing teams through multiple layers of management. Strong knowledge of pharmaceutical manufacturing operations and regulatory expectations. Experience with sterile pharmaceutical manufacturing processes. Experience supporting FDA or other regulatory inspections and internal or external quality audits. Demonstrated success improving manufacturing performance, productivity, quality, cost, and operational reliability. Experience managing performance through manufacturing metrics such as OEE, output, deviations, scrap, rework, and Right-First-Time execution. Strong experience with people leadership, organizational development, and performance management. Excellent analytical, technical, communication, and cross‑functional leadership capabilities. Preferred Skills Experience with terminal sterilization and lyophilization is strongly preferred. Manufacturing Environment The position operates within a large-scale, multi‑shift sterile pharmaceutical manufacturing environment serving regulated healthcare markets. The operation includes capabilities such as: Aseptic filling Component preparation and capping Quality Control and Microbiology laboratories Engineering and maintenance infrastructure The facility operates under FDA oversight and cGMP requirements, with operational excellence, regulatory readiness, manufacturing reliability, and supply continuity serving as critical priorities. Why Consider This Opportunity? This is an opportunity to lead manufacturing operations within a large, strategically important pharmaceutical site where operational performance directly supports the availability of essential healthcare products. The Senior Director will have significant influence over manufacturing strategy, organizational capability, quality performance, productivity, regulatory readiness, continuous improvement, and the site's ability to reliably supply customers. For an experienced pharmaceutical manufacturing leader, the position offers the scale and complexity of a major manufacturing operation together with meaningful exposure to senior site and enterprise leadership. #J-18808-Ljbffr
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