Director, Quality Assurance

Reporting Relationships

• 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 control, validation, investigations, CAPA, change control, supplier qualification, and audit management.
• Demonstrated experience leading regulatory inspections and managing responses to regulatory observations.
• Strong knowledge of Quality Management Systems (QMS) and risk-based quality management principles.
• Experience interpreting and implementing regulatory guidance, industry standards, and quality compliance requirements.
• Excellent analytical, problem-solving, leadership, organizational, and communication skills.
• Proficiency with electronic Quality Management Systems (eQMS), Microsoft Office Suite, and applicable quality documentation systems.
• Regulatory Compliance & Quality…