Director, Quality Assurance

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Full Time Management E Brunswick, NJ, US

7 days ago Requisition

Salary Range: $ To $ Annually

This position is responsible for providing strategic and operational leadership for the Quality Assurance function to ensure compliance with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements, including FDA, DEA, and other global regulatory agencies. The Director leads quality systems, regulatory inspection readiness, internal and external audit programs, supplier qualification, validation oversight, batch disposition, investigations, and continuous quality improvement initiatives.

This role partners cross-functionally with Manufacturing, Research & Development, Engineering, Technical Services, Regulatory Affairs, and other business functions to develop and maintain compliant quality systems, drive corrective and preventive actions (CAPA), and ensure products, processes, facilities, and vendors consistently meet regulatory and company quality standards.

• This is a supervisory leadership role responsible for overseeing 3 direct reports and 18 indirect reports.

• Provide strategic leadership and oversight of the Quality Assurance department to ensure compliance with cGMP regulations, FDA, DEA, and other applicable regulatory requirements.
• Direct and maintain the organization's quality systems to ensure continuous inspection readiness and regulatory compliance across manufacturing operations.
• Serve as the primary site coordinator for regulatory inspections, including FDA, DEA, customer, and third-party audits, ensuring successful inspection outcomes and timely resolution of observations.
• Lead quality oversight of manufacturing operations, contract manufacturers, contract packagers, contract testing laboratories, and suppliers to ensure compliance with established quality standards.
• Develop, implement, and maintain quality compliance strategies, policies, procedures, and systems aligned with business objectives and evolving regulatory requirements.
• Lead and oversee Corrective and Preventive Action (CAPA) activities, ensuring investigations are completed effectively and corrective actions are implemented and sustained.
• Review and approve validation protocols, validation reports, quality system documentation, investigations, deviations, change controls, and other Quality Management System (QMS) records.
• Exercise independent authority for batch disposition decisions, including approval or rejection of manufactured products based on compliance with established quality standards.
• Ensure deviations, nonconformances, and manufacturing investigations are thoroughly evaluated, documented, and resolved in accordance with regulatory expectations.
• Develop, implement, and manage the internal self-inspection program to assess compliance, identify risks, and drive continuous improvement initiatives.
• Oversee vendor qualification and auditing programs, including audits of raw material suppliers, packaging vendors, contract manufacturers, and contract laboratories.
• Partner with cross-functional departments including Research & Development, Manufacturing, Engineering, Technical Services, and Regulatory Affairs to establish compliant processes supporting product development and commercial manufacturing.
• Interface with regulatory agencies and external stakeholders regarding quality-related matters and represent the organization during inspections and compliance activities.
• Facilitate implementation of new quality systems, technologies, and process improvements that enhance compliance and operational efficiency.
• Chair or actively participate in Site Management Review Board (MRB) meetings and provide quality leadership for organizational decision-making.
• Provide leadership, coaching, performance management, and professional development for Quality Assurance personnel while fostering a culture of quality and regulatory compliance.
• Evaluate training needs and ensure personnel maintain required competencies related to cGMP regulations and quality systems.

• Bachelor's degree in Biology, Chemistry, Biochemistry, Pharmacy, or a related scientific discipline.
• Minimum of ten (10) years of progressive Quality Assurance leadership experience within a cGMP-regulated generic pharmaceutical manufacturing environment, including oversight of Oral Solid Dosage (OSD) manufacturing, quality systems, validation, regulatory inspections, and management of Quality Assurance personnel.
• Extensive knowledge of current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), FDA regulations, DEA regulations, and applicable domestic and international pharmaceutical regulatory requirements.
• Comprehensive understanding of pharmaceutical manufacturing, quality assurance, quality…