Director/Senior Director of Asset Quality Assurance
Core
Designing quality frameworks and risk strategies for AI-native biotech drug development assets to accelerate programs from preclinical to commercial launch.
Role type
Senior IC Director/Senior Director of Asset Quality Assurance
Builds
Quality frameworks, risk mitigation strategies, and audit-readiness plans for clinical, nonclinical, and CMC development.
Domain
Biopharma / AI-enabled drug development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality by Design (QbD) integration, risk and opportunity mapping, in-licensing due diligence, regulatory intelligence (FDA/EMA/ICH), GxP proficiency (GLP/GCP/GMP), program-level risk management, cross-functional leadership without direct authority, first-principles thinking, data-driven automation leverage.
Preferred skills
Experience transitioning assets from early-stage to commercial, managing strategic transactions (acquisition/out-licensing), leveraging AI-enabled technology and real-world data.
Technologies
AI-enabled technology, real-world data, digital tools, automation.
Responsibilities
Embed Quality by Design principles into development plans; identify quality risks and establish mitigation strategies; assess quality health of external target assets; drive audit-readiness for commercial launch or out-licensing; interpret global regulatory expectations in digital/AI environments.
Seniority
Senior Director, strategic leadership & cross-functional influence