Darlene Gabriel Chiu

About Darlene Gabriel Chiu

Results-driven Quality Leader with over 28 years of global Quality and Regulatory operations experience in the biopharmaceutical and medical device industries. Expertise in navigating global Regulatory frameworks and simplifying large, complex Quality systems. Championed process excellence, continuous improvement, and consent decree remediation. Adept at fostering a culture of quality, strategic planning, and cross-functional collaboration. Core Competencies: • Quality Systems Transformation • Consent Decree Remediation • Process Improvements • Operational Excellence • Audit & Enterprise Risk Management • Regulatory Compliance • Lifecycle Management

Experience

1. Deloitte Advisory Manager

   Deloitte

   Aug 2015 — Present · Costa Mesa, CA, US

   Led several global Digital, ISRM, Quality, Regulatory and IT transformation initiatives for global life science and healthcare companies, resulting in modernized and innovative frameworks, enhanced compliance and operational efficiency (e.g, eQMS, strategic program governance, quality metrics dashboards for Management Reviews, data-driven decision-making and continuous improvement).• Developed, improved, and implemented risk-based quality management systems, policies, and procedures to ensure compliance with global GxP regulations, enabling alignment with evolving regulatory standards (FDA, EU, ICH).• Mentored corporate Quality and Regulatory leaders for successful health authority inspections and audits.• Spearheaded crisis management efforts, providing guidance on compliant resolutions to defects and Regulatory issues.• Authored Regulatory compliance points of view and led RFP responses for multi-million-dollar engagements.Achievements:• Facilitated successful go-lives of a $4.5 billion global medical device SAP implementation, contributing to increased ROI and minimal customer impact with 100% successful order processing across all franchises.• Mobilized Quality system remediation plans, enabling company sales resumption within one year of consent decree.• Spearheaded expert Quality panels for Readiness & Sustaining CAPA program management, monitoring QMS health and oversight of investigations, resulting in 50% process performance improvements.