Principal Quality Consultant | Fractional Head of Quality
Fractional & Interim Head of Quality
Hands-on Quality leadership built around real operating needs.
Linda Hsieh is a quality executive with more than 20 years of experience providing senior, hands-on Quality expertise to pharmaceutical, biotechnology, medical device, 503B outsourcing facility and cosmetic organizations.
She advises executive teams on scalable Quality Management Systems, CMC Quality, supplier oversight, inspection readiness and regulatory compliance across clinical and commercial operations.
Linda has directly participated as a subject matter expert in several FDA, regulatory agency, and standards body inspections over her 20+ year career. She is available for fractional Head of Quality, project-based, and interim leadership engagements.
Selected career highlights
Hands-on experience across regulated products, outsourced operations and quality systems.
Hands-On Quality Leadership
Fractional and interim Head of Hands-on Quality leadership for emerging and virtual life-science companies.
Global Supplier Quality
Qualification and auditing of CDMOs, CROs, contract laboratories, API manufacturers, packaging suppliers and logistics providers.
CMC Quality
Supplier qualification, technology transfer, validation, batch disposition, quality agreements, remediation and commercialization support.