Soleil Labs, LLC

The Associate Director/Director, Quality Assurance (GMP) is responsible for ensuring the quality and compliance of clinical-stage GMP manufacturing and supply activities, providing quality oversight across GMP operations including batch disposition, documentation review, and vendor management. This role involves maintaining compliance with FDA, EMA, and ICH regulations while collaborating closely with Manufacturing, CMC, Supply Chain, and Regulatory Affairs to ensure material integrity.

This role will lead and execute global regulatory strategy and operations, overseeing both Clinical and CMC regulatory functions to support therapeutic development. Key duties include leading IND/CTA submissions, managing agency interactions, and providing expert regulatory guidance across development phases.