Operations Manager

Diagnostica Stago•Budd Lake, NJ

11d•Onsite

About The Position

The Operations Manager will be responsible for overseeing daily operations, including manufacturing scheduling, procurement, receiving, shipping, and equipment utilization. This role requires ensuring all processes and documentation meet ISO 13485 and FDA requirements, supporting audit readiness, and leading CAPA activities. The manager will also monitor and report on Key Performance Indicators (KPIs) such as On-Time In-Full (OTIF), throughput, customer satisfaction, and supplier surveys. Responsibilities include developing analytical methods for supply chain and customer service performance, collaborating with finance on inventory accuracy and standard costs, and managing an equipment maintenance program. The role also involves developing and updating Standard Operating Procedures (SOPs) to cGMP standards and providing reports to various business units.

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.

Nice To Haves

Knowledge of ISO 13485, cGMP, and FDA regulations within the IVD industry.
Experience in reagent/chemical manufacturing (or a similar industry).
Experience in supply chain/logistics.

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.
Support audit readiness for internal and external reviews and lead 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).