Job Description

Job Description

Required Qualifications

• Bachelor’s degree in Engineering or related technical discipline.
• 8+ years of experience in manufacturing operations or production management, including leadership of teams and involvement in process or project engineering.
• In-depth knowledge of GMPs, OSHA, and ISO regulations.
• Experience in a regulated manufacturing environment (FDA, EPA, etc.).
• SAP, Warehouse Management Systems (WMS), and manufacturing floor systems.
• Lean, Six Sigma, or continuous improvement methodologies.

Overview:

The Operations Manager is responsible for leading manufacturing operations, with full accountability for production performance, safety, quality, and cost optimization. This leader will drive day-to-day execution while fostering a culture of continuous improvement, teamwork, and operational excellence. The ideal candidate brings a strategic, end-to-end supply chain perspective and demonstrates strong leadership through innovation, communication, and accountability.

Key Responsibilities

Operational Leadership

• Lead all production areas to ensure efficient operations and compliance with GMP, FDA, safety, and quality standards.
• Manage, develop, and support Supervisory Operations Team Leaders and Technicians.
• Promote a culture of accountability and high performance through effective communication and leadership that aligns with core principles.
• Collaborate with cross-functional partners in Maintenance, Engineering, Quality, and Environmental Health & Safety to enhance plant performance.
• Partner with external suppliers and service providers to ensure the quality and consistency of operational support.
• Champion a facility-wide culture of Safety, Quality, and Productivity.
• Ensure timely SOP reviews and readiness for internal and external audits in partnership with the Quality team.
• Implement Factory Performance & Reliability standards, with a focus on People Capability, Visual Workplace, Autonomous Maintenance, and Continuous Improvement.
• Lead the development of contingency plans for business continuity.

Financial Performance

• Share responsibility for plant financial results in partnership with site leadership.
• Drive Fund-the-Growth savings through labor cost reduction and cost improvement initiatives.
• Monitor material, labor, and production variances; analyze root causes and report findings to senior leadership.
• Manage operating expenses, capital investments, and inventory levels to improve cash flow.
• Define and track KPIs to drive performance and accountability.

People Development

• Implement strategies to address workforce and labor-related challenges.
• Foster a motivated, team-based culture that supports high performance and career development.
• Ensure ongoing training and capability-building for both salaried and hourly team members.

Quality Assurance & Compliance

• Ensure compliance with product release specifications and SOPs.
• Make decisions on non-conforming raw materials, packaging, in-process materials, and finished goods.
• Oversee traceability processes including lot tracking, code dating, and production documentation.
• Maintain alignment with microbiological standards and ensure validated changeover and cleaning processes are followed.
• Lead corrective and preventive actions (CAPA), ensuring documentation, training, and implementation.
• Support new product and process launches by validating readiness and acceptance criteria during technology transfers.

Process Capability & Control

• Identify and monitor critical process parameters and product characteristics; set and review site capability goals.
• Establish process control specifications including tolerances, calibration practices, and SOP standards.
• Act on out-of-control conditions and ensure compliance with documentation and escalation protocols.

Equipment Management

• Understand plant equipment capabilities and resolve operational constraints through partnership and technical problem-solving.
• Ensure personnel are trained in cleaning, sanitization, and safe operating procedures.
• Maintain up-to-date SOPs for equipment operation, setup, and changeovers.
• Drive implementation of preventive maintenance programs to improve uptime and equipment reliability.

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