About Linda Hsieh
Principal Quality Consultant
QMS, GMP, supplier quality and fractional Head of Quality support
Hands-on quality work built around real operating needs
Linda Hsieh is a hands-on quality consultant with more than 20 years of experience in pharmaceutical, biotechnology, medical device, combination product, 503B and cosmetic companies.
Since 2018, through LH Quality Consulting, she has served as Principal Quality Consultant or fractional Head of Quality for 15+ companies, most of them early-stage or virtual teams without an in-house quality department. She builds and remediates quality systems, audits CDMOs and suppliers worldwide, oversees GMP manufacturing and prepares teams for FDA inspections.
She has supported 10+ regulatory inspections and certification audits, including 7 FDA inspections in front-room and back-room roles, all concluded successfully. Earlier in her career, she held quality management, compliance, engineering and validation roles at drug, device, combination product, cell therapy and diagnostics companies.
Selected career highlights
Quality Systems
6 quality systems built or remediated as a consultant. Earlier, built an ISO 13485 implantable device system that achieved certification and CE marking under AIMDD.
CMC and Combination Products
CMC oversight from tech transfer through NDA submission and commercial launch. Built a 21 CFR Part 4 combination product QMS.
Global Supplier Quality
20–25 GMP, GDP and GCP audits a year of CDMOs, CROs, labs and suppliers, with audits in 16 countries on 5 continents.
Regulatory Submissions
IND and NDA document reviews for 6 products. Supported IDE submissions and compiled manufacturing, release-testing and stability data for regulatory filings.
Tell me what you’re working on
Project-based, fractional and interim engagements, sized to your stage and your team.
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