Director, Quality Assurance

POSITION SUMMARY The Director, Quality Assurance drives quality performance, regulatory compliance, and inspection readiness across Empower's 503A and 503B operations. This role owns quality systems, audit governance, supplier quality, validation oversight, and compliance execution supporting patient safety and business growth. Leveraging AI-enabled analytics, predictive monitoring, and digital quality systems, the position improves decision-making, compliance visibility, and execution consistency. Success requires strategic thinking, execution rigor, learning agility, and leadership within a hyper-growth, regulated environment. Talent demonstrates accountability, operational discipline, and quality leadership supporting compliance excellence, inspection readiness, and enterprise performance. RESPONSIBILITIES Quality Leadership Quality Oversight : Leads Quality Assurance operations ensuring compliance with FDA regulations, cGMP requirements, and industry standards. Utilizes AI-enabled analytics and monitoring tools to strengthen compliance visibility, improve execution consistency, reduce regulatory risk, and support scalable quality performance while maintaining product integrity and patient safety across regulated manufacturing environments. Inspection Leadership : Directs inspection readiness, including preparation, execution, and response management for audits. Leverages AI-powered compliance tools and reporting platforms to improve readiness visibility, accelerate remediation, strengthen documentation accuracy, and ensure successful inspection outcomes while reinforcing enterprise quality systems. Audit Governance : Oversees internal audit programs that assess quality systems and compliance. Applies AI-assisted analytics to identify gaps, improve processes, accelerate issue resolution, and reinforce continuous improvement initiatives supporting enterprise compliance and operational performance. Quality Systems Supplier Quality : Directs supplier quality programs, including qualification, monitoring, and auditing across vendors. Utilizes AI-enabled analytics and dashboards to improve supplier oversight, mitigate risks, and ensure consistent product quality across the supply chain. Validation Oversight : Provides leadership for validation activities including equipment, process, and system validation. Leverages AI-powered analytics to improve process robustness, strengthen compliance, reduce variability, and support reliable manufacturing performance. Systems Management : Oversees quality systems, including training, document control, and records management. Applies AI-enabled automation and digital tools to improve efficiency, strengthen data integrity, and support scalable quality operations. Regulatory Compliance Compliance Execution : Ensures adherence to FDA regulations, USP standards, and cGMP practices. Utilizes AI-enabled monitoring and analytics to strengthen compliance execution, improve oversight, and reduce regulatory risk. CAPA Management: Oversees deviations, investigations, CAPAs, and change controls. Applies AI-powered analytics to improve root cause identification, strengthen corrective actions, and enhance quality system effectiveness. Risk Governance: Leads risk management efforts to identify compliance vulnerabilities and operational gaps. Leverages predictive analytics to #J-18808-Ljbffr