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Operations Manager

East Hanover, New Jersey
Compensation: $93,000 to $120,000 per year

This IVD (in vitro diagnostics) manufacturer is hiring an Operations Manager to oversee daily manufacturing operations, quality compliance, and supply chain performance. This role manages staff, scheduling, procurement, and equipment utilization while ensuring processes and documentation meet ISO 13485 and FDA requirements.

Schedule: Full time, on site.

Compensation: $93,000 to $120,000 per year.

What You'll Do:
This Operations Manager will recruit, train, and oversee staff while managing daily operations including manufacturing scheduling, procurement, receiving, shipping, and equipment utilization. This role ensures processes, documentation, and batch records meet ISO 13485 and FDA requirements, supports audit readiness for internal and external reviews, and leads CAPA (Corrective and Preventive Action) activities. Responsibilities include managing and monitoring KPIs such as OTIF, throughput, customer satisfaction, and supplier survey results, presenting findings to leadership, and developing methods to analyze supply chain and customer service performance with actionable solutions. This person will collaborate with the finance team to review inventory accuracy and product standard costs, ensuring cost of goods and profit margins align with company objectives, and will oversee a comprehensive equipment maintenance program including calibration, preventive maintenance, and spare parts availability. This role also develops and updates SOPs to cGMP standards and provides accurate, timely reports to related business units including customers, management, finance, and RAQA.

Required Qualifications:

• Bachelor's degree from a four year college or university (Business, Supply Chain/Logistics, or Sciences)
• 4 to 5 years of managerial or supervisory experience

Preferred Qualifications:

• Knowledge of ISO 13485, cGMP, and FDA regulations within the IVD industry
• Experience in reagent/chemical manufacturing or a similar industry
• Supply chain/logistics experience

Compensation and Benefits:

• $93,000 to $120,000 per year
• Medical, dental, and vision insurance
• 401k retirement plan
• Paid time off 

To apply, submit your resume and a summary of relevant operations and quality management experience for review.