Hiring: Director, Quality Operations Company: BioTissue Location: Miami, FL Job Posted Time: 2026-09-15 13:52:38 Target Skills & Keywords : Microsoft Excel, Quality Assurance, Risk Management About the job Experience: •15 years of experience in an FDA-regulated industry, required •5 years of Quality Assurance and people management experience, required •5 years of experience utilizing an electronic Quality Management System (eQMS), required •2 years of experience working with Enterprise Resource Planning (ERP) systems, preferred •Minimum 15 years of experience in an FDA-regulated industry, required Required Skills: •This role is responsible for departmental budgets, resource allocation, and daily quality operations while fostering a culture of accountability, problem-solving, professional development, and continuous improvement. •Lead and develop all aspects of site quality-operations, including manufacturing, packaging, labelling, distribution, quality engineering ensuring consistent execution of quality standards and alignment with organizational objectives. •Ensure compliant product disposition and release in accordance with GMP, GTP, ISO and other applicable regulations. •Champion the application of GxP, ISO, and AATB quality principles to drive product and process improvements through effective utilization of Quality Management System elements, including Change Control, Nonconformance Management, Quality Engineering, CAPA, Risk Management, and Audit programs. •Serve as a key leader in advancing a strong quality culture across the organization, influencing both internal and external stakeholders while driving continuous improvement of the site Quality Management System. •Establish priorities, allocate resources, and manage team workloads to support manufacturing and supply chain objectives while monitoring performance metrics and ensuring achievement of departmental goals. •Partner closely with Operations leadership to align quality strategies, business priorities, and operational objectives, enabling efficient and compliant execution of manufacturing activities. •Act as the site Quality subject matter expert, maintaining deep knowledge of quality systems, standard operating procedures, work instructions, and regulatory requirements, while ensuring effective integration and execution of all quality processes. Qualifications: •Sedentary work that generally requires sitting and/or standing Compensation: •$156,079 - $195,098 / year •Medical, Dental, and Vision Insurance Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!