Global Quality & Regulatory Affairs Leader

Werfen seeks a Head of Quality and Regulatory Affairs in San Diego to lead quality systems, regulatory strategy, and post-market surveillance for Autoimmunity products. You will guide senior leadership, coordinate with cross-functional teams, and ensure compliance with FDA, ISO, and global standards.

You will oversee submissions, training, and risk management, supervise QA/QC staffs, and drive improvements across the organization to support regulatory approvals and commercialization.