Quality Assurance Manager – Manufacturing

The Quality Assurance Manager (Manufacturing) is responsible for oversight of quality assurance activities related to business operations units, as defined by the quality management system, applicable FDA regulations, ISO requirements, and current certifications. This role provides support and guidance to QA associates and advises management on continuous improvement efforts aligned with company strategy and regulatory standards.

Day-to-day responsibilities include directing the CAPA program, conducting internal audits of the Quality Management System, performing root cause analysis across manufacturing groups, and leading complaint investigation efforts. The manager also ensures organizational QMS training is in place and provides technical support for process documentation changes.

This is an onsite position at the Phillipsburg, NJ site. The QA Manager works directly with customers and suppliers to communicate critical features, requirements, and corrective actions, and coordinates objectives with production procedures to maximize product reliability and minimize costs.

The role provides strategic insight to senior management and ensures integration of FDA regulations and other regulatory bodies into the QMS. By maintaining cGMP compliance and overseeing inspection activity throughout the production cycle, the manager drives quality and operational excellence across the organization.