Operations Manager

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:

• Bachelors degree from a four-year college or university required (Business Supply Chain/Logistics or Sciences).
• Minimum of 45 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.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

We offer an extensive benefit and compensation package that includes medical dental vision 401k PTO life and disability insurance as well as a comprehensive leave program. Pay anticipated for this position in New Jersey is from $93000-$120000 depending on a number of the ordinary course of business compensation and benefits programs may change based upon the Companys needs.

All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin citizenship disability or protected veteran status.

Required Experience:

Manager