Profile: SME in audit, CMC, GMP, quality system, CMO oversight, drug product, packaging & labeling, risk management, gap assessment & remediation and drug-device combination product. Author CMC sections and support PAI. Interim Quality Head. ASQ Certified Quality Engineer and Auditor. Lead auditor for 50+ audits in 2021 to 2022. Performed 21 audits in 1st half of 2022. Audited RSM, intermediate, API, DS, DP, OSD, sterile fill-finish, Packaging & Labeling, Contract Test Lab, Storage, Distribution, and Devices. Compliance (21 CFR Part 211/820/4), quality systems, regulatory submission (IND, NDA/BLA), packaging (DS, DP, bottle, form/fill/seal), quality and supply agreement, batch record review & release, CAPA, deviation, change control, investigation, control strategy, risk management (HA, FMEAs), statistical analysis, complaint handling, biocompatibility, validation (IQ/OQ/PQ), CMO oversight and manage. Audited in US, UK, EU, Korea, China. Language expertise: Korean fluently. Based in United States.