Director/Senior Director of Asset Quality Assurance

Role: Lead Quality strategy for AI-driven biopharma asset development, integrating Quality by Design principles into clinical, nonclinical, and CMC plans to accelerate programs. Responsibilities: partner with asset teams to embed risk-based quality frameworks, conduct quality assessments during due diligence, ensure audit-readiness, and interpret global regulatory expectations (FDA, EMA, ICH) in digital/AI contexts. Requirements: Bachelor's or higher in science or engineering; extensive GxP experience across GLP, GCP, GMP in fast-paced biotech; proven ability to influence cross-functional teams and senior stakeholders; expertise in quality assessments for early-stage to commercial assets and navigating regulatory transitions. HighValue: biopharma, AI-enabled drug development, asset risk management, quality by design, GxP compliance, global regulatory standards, cross-functional collaboration. WorkSetup: hybrid in New York City, Boston, Research Triangle, or San Francisco; 3 days onsite; relocation preferred for non-local candidates.