Minimum Requirements + Bachelor’s Degree in a scientific discipline, life science, or related technical discipline + 8+ years of experience in the biotech, pharmaceutical, medical device, biologics, OR related regulated industry with a Bachelor's Degree OR + 6+ years of experience in the biotech, pharmaceutical, medical device, biologics, or related regulated industry with a Master's Degree + 5+ years of demonstrated experience of Quality Systems principles, practices, and processes such as CAPA, Change Control, Management Review, and Data Analysis in a GMP Quality Assurance role + Demonstrated experience establishing, implementing, and/or managing a regulatory intelligence program within a regulated industry (e.g., pharmaceutical, biotech, medical devices) + Working knowledge of Code of Federal Regulations (CFR) 210, 211, 820, Part 11, and/or other related FDA federal regulations and the ability to analyze regulations and apply them to Quality Systems and processes + Experience with the management review processes requirements + Experience managing product recalls and mock recall activities, including cross-functional coordination and regulatory interaction + Experience monitoring and reporting compliance metrics and KPIs to senior management + Strong analytical, communication, and stakeholder engagement skills to effectively drive compliance initiatives + Foster a culture of collaboration, partnership, teamwork, and continuous improvement Preferred Requirements + Master’s Degree in engineering, chemistry, or other physical science field + 3+ years of experience in a Quality Assurance Manager role in a GMP-regulated environment + Knowledgeable or experience in using Quality Management System software applications such as Trackwise Digital, MasterControl, etc. + Coordinate product recall process, including planning, execution, documentation, and continuous improvement + Maintain recall readiness through periodic mock recall + Maintain established key quality performance indicator (KPI) and supporting KPI tool (e.g., Power BI) to develop dashboard and communicate periodic metric report to site management and executive leadership + Prepare and deliver training on KPI tool use, report, and dashboard across all site, as needed + Analyze compliance trend and metric, identify risk or gap, and provide clear, data-driven reporting to management + Coordinate corporate level management review activity by compiling, presenting, and interpreting compliance data and effectiveness of quality system control to management + Lead assigned Quality Management System improvement initiative, ensuring process align with UTC expectation and applicable regulatory requirement.