Dynamic leader with established success at University Medical Pharmaceuticals Corp., excelling in product development and regulatory compliance.
Overview
19
19
years of professional experience
Work History
Director of Dermatological Devices
Golden Hippo
Woodland Hills, CA
01.2025 - Current
Strategic sourcing of Class II OTC photobiomodulation devices, quality management, regulatory compliance, and distribution within a QMSR/ISO 13485 framework using Deposco WMS, NetSuite ERP, and Salesforce CRM; CSCP (enrolled/in process)
Spearheaded inventory, operational, and regulatory readiness for human and pet device launches.
Implemented eQMS (Qualio) and SOPs for AEs, complaint handling, IQC, recalls, and traceability.
Achieved 84% gross margin on low MOQs.
Compliance testing of finished goods enabling air freight for Dangerous Goods from northern China.
VP, Operations, Quality, and Regulatory
Joylux, Inc.
Seattle, WA
01.2024 - Current
Orchestrate comprehensive operational strategies for medical device manufacturing and quality management systems.
Supervise international supply chain operations across American and Chinese contract manufacturers.
Administer Person Responsible for Regulatory Compliance (PRRC) duties including ISO 13485 and MDSAP audits.
Manage multi-channel logistics operations encompassing air freight, B2B, D2C, customs, drop-ship, international logistics, LCL, LTL, MABDs, ocean freight.
Spearheaded operational readiness for cosmetic and device launches with Halle Berry/RESPiN and Essity/Issviva.
Advanced and updated QMS SOPs for CAPAs, complaint handling, ECOs, NCMRs, RCA, and SCARs.
Achieved a 510(k) clearance from a third party reviewer by leveraging new bridging data.
Vice President of Operations and Combination Product Development
University Medical Pharmaceuticals Corp.
Irvine, CA
01.2014 - 01.2023
Directed development initiatives for innovative dissolvable microneedle array technologies and manufacturing processes.
Established strategic partnerships with Key Opinion Leaders in drug delivery and infectious disease sectors.
Accelerated company revenue growth by 300% from $25MM to $75MM in five years through supply chain optimization and automated inventory management.
Generated $4.3MM annual cost savings through strategic formulation reverse-engineering and enhanced supply chain resilience.
Delivered $35MM revenue growth in 9 months by developing and launching new OTC antibacterial and antiseptic product lines.
Secured acquisition bids exceeding $200MM and negotiated 33% purchase price increase of $16MM through operational excellence initiatives.
Expanded market presence by establishing partnerships with Fortune 50 retailers including Bloomingdales, Harrods, Nordstrom, and Ulta, generating $1MM+ in new revenue.
Patents
Microneedle devices for delivery of mRNA pharmaceuticals, and methods of manufacturing microneedle devices, U.S. Provisional Application No.: 63/351,501, 2022
Microneedle devices for delivery of bioactive agents, and methods of manufacturing microneedle devices, U.S. Provisional Application No.: 63/332,296, 2022
Process and system for iontophoretic wrinkle reduction, US 9913977B2, 2018
Process and system for iontophoretic wrinkle reduction, US8747383A2, 2014
Timeline
Director of Dermatological Devices
Golden Hippo
01.2025 - Current
VP, Operations, Quality, and Regulatory
Joylux, Inc.
01.2024 - Current
Vice President of Operations and Combination Product Development
University Medical Pharmaceuticals Corp.
01.2014 - 01.2023
Vice President of Operations and Product Development