Qpex Biopharma Inc
San Diego, CA
Overview The Director of Quality provides strategic and operational leadership for Quality Assurance across Qpex's multi-therapeutic, multinational Phase 1-3 infectious disease development programs. This role is responsible for designing, implementing, and overseeing robust global quality systems that ensure compliance with FDA, ICH, GLP, GCP, and GMP requirements. Working closely with executive leadership, Regulatory Affairs, Shionogi Quality partners, CMOs, and external consultants, this role ensures quality oversight across development, manufacturing, testing, and product release activities. The position leads internal teams and external vendors, supports regulatory submissions and inspections, and drives continuous improvement of quality systems to enable successful regulatory approvals and commercialization. Detailed Description Primary Duties and Responsibilities include: Direct multi-therapeutic, multi-national quality assurance oversight in Phase 1-3 drug development...