Hands-On Quality Leadership
Fractional Head of Quality, interim leadership, quality strategy and executive advisory.
LH QUALITY CONSULTING
FDA, GMP & Quality Consulting
Hands-on Quality leadership for pharmaceutical, biotechnology, medical device, 503B and cosmetic organizations. Provide senior, hands-on Quality support for small and emerging life-science companies that need experienced expertise without building a large Quality organization.
Linda Hsieh provides fractional Head of Quality, interim and project-based support across QMS, CMC Quality, supplier oversight, inspection readiness and regulatory compliance.
WHERE I HELP
Senior quality support, focused on the work that matters.
I work directly with leadership and cross-functional teams to build practical quality systems, address compliance risks and keep development and manufacturing moving.
Quality Systems & Compliance
QMS design and remediation, CAPA, investigations, change control and inspection readiness.
CMC & Supplier Quality
Manufacturing quality, technology transfer, validation, batch disposition, CDMO oversight and audits.
20+ YEARS OF QUALITY EXPERIENCE
Experienced when you need it. Hands-on when it counts.
Hands-on Quality expertise across clinical development through commercial manufacturing, with experience in QMS, CMC Quality, supplier oversight, compliance, and quality remediation.
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