Director/Senior Director of Asset Quality Assurance
Core
Designing quality frameworks and embedding Quality by Design (QbD) principles into drug development programs to accelerate assets from preclinical to commercial phases.
Role type
Senior Director, Biopharma Quality Assurance
Builds
Lean, risk-calibrated quality frameworks for AI-enabled drug development assets
Domain
Biotechnology / Pharmaceutical Quality Assurance
Deliverable
production ML models
Required skills
Quality by Design (QbD), GxP proficiency (GLP, GCP, GMP), asset due diligence, regulatory intelligence (FDA, EMA, ICH), risk mapping, cross-functional leadership, first-principles thinking, data-driven process optimization
Preferred skills
Experience with AI-enabled technology in drug development, experience with in-licensing and acquisition readiness, managing program-level risk frameworks
Technologies
AI-enabled technology, real-world data platforms, digital compliance tools
Responsibilities
Partner with asset development teams to integrate QbD into clinical, nonclinical, and CMC plans; Identify quality risks and establish mitigation strategies for assigned Asset Pods; Assess quality health of external target assets during due diligence; Drive audit-readiness strategy for commercial launch or out-licensing; Interpret global regulatory expectations in digital and AI-accelerated environments
Seniority
Senior Director, strategic leadership & cross-functional influence