• Serve as the Global Business Process Owner for the TrackWise eQMS, ensuring continuous system improvement and comprehensive user support.• Present key quality metrics and KPI dashboards to senior leadership to facilitate data-driven decision-making.• Oversee GXP processes, including change control, deviations, CAPA, and investigations, ensuring compliance with FDA, EU, and other global standards.• Implemented a 21 CFR Part 11 compliant electronic system and conducted GxP training to support ongoing compliance and improvement initiatives.• Led cross-functional teams on digital transformation projects that enhanced system efficiency and aligned with organizational quality goals.• Managed external supplier audits and drove inspection readiness activities, serving as a primary contact for regulatory inspections and audit responses.

• Managed quality system processes and led the vendor quality management program, including audit schedules and CAPA implementations.• Directed internal audit programs and hosted inspections by health authorities, ensuring the organization maintained a state of readiness.• Provided training and guidance on cGxP, enhancing awareness and fostering a culture of continuous improvement.• Oversaw the development of quality metrics, leading to improved data-driven strategic decisions during board meetings

• Managed clinical laboratory licensure, FDA registrations, and regulatory compliance for regional laboratories.• Supported both domestic and international regulatory inspections, ensuring consistent inspection readiness.• Led quality system audits, reviewed validation protocols, and contributed to 510(k) testing platforms and IND clinical trials.• Developed quality system metrics and presented findings to senior management, enhancing process efficiency

• Facilitated deviation management, CAPA processes, and internal audits to promote continuous improvement.• Conducted computer system and equipment validations, ensuring compliance with regulatory standards.• Played a key role in hosting agency inspections, demonstrating robust adherence to quality protocols.• Participated in Kaizen and Lean Six Sigma initiatives, achieving streamlined operations and cost savings