<p>A growing organization within the pharma /healthcare warehousing space is seeking a hands-on <strong>Quality Assurance Manager </strong>to lead quality, regulatory, and safety programs across regulated warehousing, fulfillment, and production environments supporting healthcare and consumer clients.</p><p><br></p><p>This role partners closely with executive leadership and operations to ensure regulatory compliance, audit readiness, and scalable quality systems while balancing business needs with regulatory requirements.</p><p><br></p><p>Key Responsibilities</p><ul><li>Lead enterprise-wide Quality Assurance and Compliance programs</li><li>Ensure compliance with FDA, DEA, OSHA, cGMP, and client-specific requirements</li><li>Own client, regulatory, and internal audits from preparation through resolution</li><li>Manage CAPA programs, investigations, and effectiveness reviews</li><li>Oversee temperature-controlled operations, excursion management, and validation</li><li>Ensure inventory integrity, traceability, lot control, and recall readiness</li><li>Maintain licenses, certifications, and audit readiness</li><li>Drive SOP governance, document control, and training compliance</li><li>Lead warehouse safety and compliance initiatives</li><li>Partner cross-functionally to identify and mitigate operational risk</li><li>Promote a collaborative, solutions-oriented quality culture</li></ul><p><br></p>
Our client in the Bridgewater area is seeking an experienced Quality Assurance Director to join their team. • Salary Range: $130-175k • In office Monday-Friday • Strong experience with ISO 9001 • Experience within the manufacturing industry is required, and experience supporting architecture, engineering, or construction (AEC) environments is strongly preferred. <br> Benefits include medical, dental, vision insurance, 401k, and PTO. <br> Director of Quality Assurance Position Overview We are seeking an experienced Quality leader to develop, implement, and oversee company-wide quality systems and initiatives. This individual will be responsible for maintaining a robust Quality Management System (QMS), ensuring regulatory compliance, and driving continuous improvement across operations. Key Responsibilities • Lead the development, implementation, and maintenance of the company’s Quality Management System (QMS), ensuring alignment with ISO 9001 standards. • Oversee quality programs to ensure product and service excellence across all operational areas. • Drive continuous improvement initiatives through data analysis, root cause investigations, and corrective/preventative action plans. • Partner cross-functionally with engineering, operations, project management, and leadership teams to embed quality standards throughout the organization. • Lead internal and external audits, ensuring compliance with regulatory and certification requirements. • Monitor quality performance metrics and present findings and recommendations to executive leadership. • Ensure the organization remains current with industry standards, regulatory requirements, and best practices.