Adrienne Mei Hwa Oreilly

WORK HISTORY

EDUCATION

SKILLS

ABOUT ADRIENNE MEI HWA OREILLY

Over a decade of industry experience in biotech, pharmaceutical, and combination product development. As a late-stage, small, virtual company\'s first Quality employee, established Phase quality system; product approved by FDA fall 2019 and EMA spring 2021. As another late-stage company\'s first Quality employee, developed the company\'s novel quality system, addressed key compliance gaps, and successfully hosted regulatory agency inspection 16 months after hire. Subject matter expertise in creation and management of robust phase-appropriate (from Phase quality systems: vendor and material qualification, batch record review and release (including QP release), material movement and inventory management, internal and external audits, management review, document control, training, deviation, CAPA, and complaint programs, SOP writing and improvement, risk management, out of specification procedures, device design control, purchasing controls, creation of quality manuals, site master files, and quality agreements, GCP and GVP QA, and for two companies, implemented (including configuring and validating) and served as sysadmin of MasterControl as an electronic quality management system (eQMS). Served as sysadmin for PSC Biotech\'s ACE eQMS, and business owner/ process owner for the implementation of Veeva\'s QualityDocs and Training modules. Experience leading and participating in domestic and international GMP (20+) and GCP audits, hosting regulatory agency inspections, client audits, management review meetings, and internal audits. Earlier industry experience includes managing, under the CEO, a small virtual company preparing for late-stage manufacturing, QA consulting - establishing quality systems at small, late-stage virtual companies (including packaging and labeling facilities, warehouses, and in-vitro diagnostics companies), clinical trial design, writing clinical trial protocols, and conducting monitoring, CMO vetting, selection, and tech transfer, qualification and oversight of GLP vendors, patent defense, writing FDA IND updates, writing publications, and presenting posters and oral presentations at domestic and international conferences.