Lumicell

Director

• Overseeing the comprehensive quality, compliance, regulatory strategy, and operational excellence of Lumicell's drug/device combination product
• Directing the integration of quality management systems, supplier quality, quality engineering, and working with regulatory affairs to ensure products meet all customer and regulatory standards from concept through post-launch
• Maintaining and continuously improving a scalable Quality Management System (QMS) to ensure alignment with QMSR, cGMP, 21 CFR Parts 210, 211, and 820, and ISO 13485 across all functional groups supporting FDA-regulated medical devices and drugs
• Developing and implementing quality systems and SOPs for device and drug quality management, ensuring alignment with cGMP and other regulatory standards
• Overseeing all Quality Engineering functions, ensuring that devices and drugs are designed and manufactured in compliance with applicable FDA regulations and ISO standards (ISO 13485, ISO 14971)
• Acting as a subject matter expert in design quality and risk management; leading the company's Management Review process
• Developing and managing quality metrics and quality objectives to monitor performance, inform management decisions, support continuous improvement initiatives, and assist in preparation of regulatory submissions for product approvals
• Leading supplier quality management for devices and drugs, managing the entire process from selection and onboarding to ongoing performance evaluations of contract manufacturers (CMOs) and other suppliers
• Directing design control activities, managing robust process validation, risk management, and ensuring compliance from concept through post-launch per 21 CFR 820.30
• Owning and managing the risk management program in accordance with ISO 14971, including hazard analysis and risk/benefit assessments across the product lifecycle
• Leading the company through FDA inspections, including serving as the primary host and spokesperson during on-site visits
• Managing all aspects of inspection, including corporate readiness, real-time coordination during the audit, preparation of Form 483 responses, and development and execution of corrective action plans submitted to regulatory agencies
• Leading and managing post-market surveillance, including device investigations for complaints and field actions, and MDR reporting
• Supporting post-market pharmacovigilance programs for the drug component, ensuring timely adverse event reporting and signal detection in compliance with 21 CFR Part 314, part 3 and applicable post-approval requirements
• Supporting all quality aspects of Clinical Affairs programs in compliance with 21 CFR 312, 21 CFR 812, and ISO 14155:2020

Senior Director of Quality