More than 20 years of hands-on Quality leadership across pharmaceutical, biotechnology, medical device, 503B and cosmetic organizations.
Hands-on Quality leadership from early development through commercial manufacturing, including QMS, CMC Quality, supplier oversight, GMP and inspection readiness.
Quality systems and supplier oversight for regulated medical devices and drug-device combination products.
Quality support for 503B outsourcing facilities and cosmetic organizations, including applicable compliance and quality-system needs.
Including transdermal patches, semi-solid topical products, cell therapy products, diagnostics and outsourced manufacturing networks.
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