SME in quality system, compliance, audit, CMC, drug product, CMO oversight, packaging & labeling, risk management, gap assessment & remediation, and drug-device combination product.

Author CMC sections in IND/BLA/NDA and support PAI. Tech transfer and outsourced manufacturing in US, EU and Asia. Interim acting Head of Quality.

Experience at big pharma (Genentech Ph 2/3 IND) and start-ups (Intarcia Therapeutics, Lightsciences Oncology Ph 2/3 IND and NDA)

Audit (GMP, PAI, mock, DD), GMP 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, process validation (IQ/OQ/PQ), CMO oversight and management.

• cGMP and QSR compliance, audit, health authority inspection.
• Phase appropriate QMS set-up, training, gap and risk assessment, identify potential concern and remediate.


• Packaging: Biologics DS and DP (vial, cartridge, PFS) and OSD, device, labeling and validation.
• Risk assessment and practice: RM plan and report, hazard assessment, process/design/use FMEA.


• CMC and BLA/NDA: IND module 2.3/3, manufacture, control, stability, CCI, MBR & release, process develop, packaging and labeling (P&L), QTPP, CMO source/select/manage, CDRH. Authored 2 BLA sections with 1 minor IR and support mock inspection/PAI.


• Drug-device combo product develop, mfg and design control: 10 pre-filled syringe, 5 pen & auto injector, nebulizer, patch pump, implantable mini-pump, blood treatment system.


• CDMO site management, oversight and governance, outsourced operations in US/EU/Asia


• ASQ Certified Quality Engineer (CQE) and ASQ Certified Quality Auditor (CQA)
• Fluent in Korean (speak, write, read) and bi-cultural as Korean-American


• Speaker and panelist at MedTech Supplier Partnership Conference 2012 and MD&M West Conference 2013
• Speaker at KASBP Symposium 2020 on "GMPs for CMC IND Ph 1 and 2/3 Clinical Phase Appropriate QMS"


• Independent Consultant and affiliated with Jeff Yuan & Associates
• 15 years experience in drug-device combo products
• 21 years experience in managing CMOs
• 26 years experience in GMP