This role builds and sustains a phase-appropriate Quality Management System (QMS) for a virtual nonprofit organization, ensuring that development activities remain integrated, risk-based, data-driven, compliant, and inspection-ready as programs advance through late-stage development, outbreak-response and emergency-use readiness, Process Performance Qualification (PPQ), Phase 3 clinical trials, regulatory submissions, inspections, licensure, and commercial readiness. Lead inspection readiness and serve as the sponsor quality lead for FDA Bioresearch Monitoring (BIMO), Pre-Approval Inspections (PAIs), surveillance inspections, and other health authority inspections, including inspection logistics, subject-matter expert preparation, document production, response strategy, and closure of regulatory commitments.