at Fagron Sterile Services in Wichita, Kansas, United States
Job Description
The Operational Excellence Manager is responsible for leading continuous improvement initiatives, optimizing operational performance, and driving standardization across multiple 503B sterile compounding facilities, across manufacturing, supply chain, and support functions within a pharmaceutical environment.
This role partners closely with Operations, Quality, Engineering, and Supply Chain leaders to improve efficiency, reduce waste, enhance compliance, and deliver sustainable cost and performance improvements—while maintaining the highest standards of product quality and regulatory compliance. The position leads a team of Operational Excellence Engineers and serves as a change agent to embed Lean, Six Sigma, and performance management principles into daily operations.
Key Responsibilities
- Lead and deploy continuous improvement strategies aligned with business objectives, regulatory requirements, and patient safety priorities.
- Identify, analyze, and implement process improvements using Lean, Six Sigma, and structured problem-solving methodologies (e.g., DMAIC, A3).
- Drive initiatives to improve operational leverage, including throughput, capacity utilization, cycle time, and labor productivity.
- Establish and maintain performance management systems, including tracking, reporting, and analyzing key Operations KPIs (e.g., OEE, yield, scrap, cost per unit, on-time delivery).
- Conduct scrap, yield loss, and deviation trend analysis, and lead cross-functional corrective and preventive action (CAPA) initiatives to reduce waste.
- Perform cost, material, and efficiency savings analyses, including business case development and benefit realization tracking.
- Partner with Operations, Quality, Engineering, Supply Chain, and Finance leaders to prioritize improvement initiatives and support strategic goals.
- Ensure improvement initiatives comply with GMP, FDA, and other applicable regulatory standards, and support audit readiness.
- Lead, coach, and develop a team of Operational Excellence Engineers, including goal setting, performance management, and capability development.
- Support change management efforts by influencing stakeholders, building engagement, and sustaining improvements over time.
- Develop and deliver training on continuous improvement tools, operational excellence principles, and data-driven decision-making.
- Provide regular reporting and executive-level updates on initiative progress, savings, and operational performance.
- Develop, implement, and sustain OpEx frameworks (Lean, Six Sigma, 8 wastes, Visual Management, 5S) across all 503B facilities.
- Identify performance gaps, perform root cause analyses, and lead cross‑functional improvement projects to reduce waste, improve workflow, and enhance productivity.
- Standardize processes, workflows, metrics, and best practices across sites to drive consistency, compliance, and operational scalability.
- Facilitate and coach teams during value‑stream mapping sessions, and problem‑solving activities.
