Operations Excellence Lead — Regulated Manufacturing

Extremity Care; Franklin (WI); On-site; USD 110,000 - 150,000; Full time

Job summary

Extremity Care is seeking a Senior Operations Manager to lead day-to-day operations, ensuring compliant, efficient performance across production, inventory, and distribution. You will coordinate with Quality, Regulatory, Supply Chain, and external partners to drive improvements and meet customer expectations in domestic and international markets.

The role emphasizes continuous improvement, KPI monitoring, and budgeting while coaching staff and aligning processes with FDA, ISO, and cGMP

Qualifications

• Bachelor's degree in a related field required.
• 5–8 years of experience in operations, manufacturing, supply chain, logistics or related functions with progressive leadership.
• Experience in a regulated environment (FDA, ISO, cGMP, GDP, GLP or similar) preferred.
• Proven track record leading teams and monitoring performance metrics.

Responsibilities

• Oversee production, facilities, maintenance, inventory and warehouse management, customer service and order management.
• Support after-hours operational needs and emergency response situations.
• Monitor KPIs and provide data-driven insights for decision-making.
• Lead continuous improvement initiatives to enhance productivity, quality, and cost control.
• Manage departmental spending and budgets in partnership with leadership.
• Collaborate across functions to implement operational excellence programs.
• Identify skill gaps and support employee development and succession planning.
• Support integration activities related to acquisitions including systems and training.
• Ensure compliance with cGMP, GDP, GLP, FDA, ISO, and customer specs across operations.
• Participate in audits and support corrective/preventive actions as needed.
• Contribute to annual budget planning, forecasting, and capital projects.
• Maintain relationships with customers, suppliers, and service providers.

Skills

Leadership & team development

Manufacturing & supply chain

Project management

Data analysis & process improvement

Budgeting & cost control

Problem solving & decision making

Communication

Regulatory compliance & ethics

Multi-tasking in fast-paced env

Technical documentation & reporting

ERP & MS Office experience

Education

Bachelor's degree in Business, Engineering, Supply Chain, Operations Management, or related field

Tools

MS Office

ERP/business management systems

Job description

Extremity Care is seeking a Senior Operations Manager to lead day-to-day operations, ensuring compliant, efficient performance across production, inventory, and distribution. You will coordinate with Quality, Regulatory, Supply Chain, and external partners to drive improvements and meet customer expectations in domestic and international markets.

The role emphasizes continuous improvement, KPI monitoring, and budgeting while coaching staff and aligning processes with FDA, ISO, and cGMP