Job Details

Essential Duties & Responsibilities:

• Recruit, train, and oversee staff while managing daily operations, including manufacturing scheduling, procurement, receiving, shipping, and equipment utilization.
• Ensure all processes, documentation, and batch records meet ISO 13485 and FDA requirements, while supporting audit readiness for internal and external reviews and leading CAPA (Corrective and Preventive Action) activities.
• Manage and monitor KPIs: OTIF, throughput, customer satisfaction, supplier survey and present findings to leadership.
• Develop methods to analyze performance in supply chain and customer service areas and provide actionable solutions.
• Collaborate with the finance team to review and refine inventory accuracy and product standard costs, ensuring that cost of goods and profit margins align with company objectives.
• Oversee a comprehensive equipment maintenance program, including calibration, preventive maintenance (PM), and ensuring the availability of required spare parts.
• Develop and manage Operational KPIs for the business.
• Develop and update SOPs to cGMP
• Provide accurate and timely reports for related business units (customers, management, finance, RAQA)

Education & Requirements:

• Bachelor’s degree from a four-year college or university required (Business, Supply Chain/Logistics, or Sciences).
• Minimum of 4–5 years of managerial or supervisory experience required.
• Strongly preferred: knowledge of ISO 13485, cGMP, and FDA regulations within the IVD industry, as well as experience in reagent/chemical manufacturing (or a similar industry) and supply chain/logistics.