Sam Khemici

Consultant

• Quality & Regulatory Affairs, IVD & Life Sciences, Global Compliance Strategist

With over 7 years of progressive leadership across the life sciences and pharmaceutical sectors, Sam specializes in quality systems, global regulatory compliance, and operational integration. Sam has led multi-site audits across the U.S., U.K., and China, securing $1M+ in savings and driving MDSAP/ISO 13485:2016 compliance.

Sam’s background spans quality engineering, microbiology, and regulatory strategy in IVD medical devices, pharmaceuticals, and biologics. He has supported successful site transfers, built supplier management systems, and played a key role in cross-border expansions and post-merger harmonization.

Expertise:

• MDSAP, ISO 13485, FDA 21 CFR Part 210/211/820

• Global regulatory frameworks (Health Canada, FDA, EU IVDR, Australia TGA)

• Audit leadership, QMS optimization, and CAPA systems

• CDMO operations, tech transfers, and risk-based quality strategy

• Certifications: ASQ Certified Quality Auditor, BSI-certified ISO 13485 & ISO 19011 Lead Auditor