Quality Assurance Manager

Responsibilities Regulatory Compliance and Inspection Readiness Ensure compliance with FDA regulations, cGMP, DEA, DSCSA, applicable state licensing requirements, and client-specific quality requirements across all 3PL operations. Maintain a constant state of inspection readiness for internal, client, and regulatory audits. Lead and support regulatory inspections and client audits, ensuring timely, complete responses to observations and follow-through on commitments. Support the internal audit (self-inspection) program and supplier/vendor qualification activities. Quality Management System Oversee and continuously improve core QMS processes, including: Deviations and nonconformances (NCs) Corrective and Preventive Actions (CAPA), including effectiveness checks Change control Document control and record retention GMP training and qualification of personnel Product complaints, returns, recalls, and temperature excursions Ensure investigations are thorough, root causes are identified, and corrective actions are effective and sustainable. Ensure data integrity and electronic record compliance in eQMS, LIMs and other GxP systems. Exercise quality authority to quarantine, hold, and release product in accordance with approved procedures. Cleanroom Sampling and Dispensing Provide quality oversight of cleanroom sampling and dispensing, which is executed day to day under the Sampling and Dispensing Supervisor. Ensure adherence to SOPs, cGMP, and aseptic practices; timely review of records, labeling, chain of custody, and line clearance; and thorough investigation and resolution of related deviations. Environmental Monitoring (EM) Oversee the cleanroom EM program, ensuring data are reviewed and trended, excursions receive timely investigation and CAPA, and cleanroom qualification, cleaning/disinfection, and monitoring requirements are maintained. Continuous Improvement and Reporting Lead initiatives that improve quality performance, reduce variation and deviations, and increase Right-First-Time (RFT) execution and operational efficiency. Analyze quality trends, metrics, and KPIs to identify systemic issues and drive data-based decisions. Report quality performance and improvement actions at management review. Client Partnership Serve as the primary quality contact for commercial clients, ensuring strong communication and partnership. Address client concerns, deviations, and quality events with urgency and transparency. Ensure client notification requirements are met in accordance with quality agreements and SOPs. Support quality agreement development, maintenance, and compliance. Team Leadership Lead, coach, and develop a team of QA professionals, including the Sampling and Dispensing Supervisor, to ensure high performance and engagement. Establish clear roles, responsibilities, and expectations for all direct reports, and participate in hiring, performance reviews, and development planning. Drive a culture of accountability, ownership, and quality excellence across the organization. Perform other duties as assigned. Qualifications and Job Specifications Bachelor’s degree in Biology, Chemistry, Engineering, or a related field (equivalent experience may be considered). Minimum of 5 years of quality experience in the pharmaceutical, medical device, or other FDA-regulated industry. Minimum of 3 years of supervisory experience. Working knowledge of state and federal laws and regulations governing warehousing and distribution of pharmaceuticals and medical devices, including FDA, DEA, PDMA, and DSCSA, with the ability to interpret and apply them. Preferred Experience in 3PL, warehouse, or distribution quality operations. Experience with cleanroom operations, sampling and dispensing, and environmental monitoring. Experience hosting regulatory inspections and client audits. ASQ certification (e.g., CQA, CQM/OE, CPGP) and/or ISO auditor certification. Technical Expertise Excellent verbal and written communication and presentation skills. S…

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