Director/Senior Director of Asset Quality Assurance
Core
Designing quality frameworks and risk strategies to accelerate drug development programs from preclinical through commercialization, leveraging AI and digital tools.
Role type
Senior Director of Asset Quality Assurance (Biopharma)
Builds
Drug development programs transitioning from R&D to commercial launch or out-licensing
Domain
Biopharma / AI-driven drug discovery
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
Quality by Design (QbD) integration, risk and opportunity mapping, asset due diligence, regulatory intelligence (FDA/EMA/ICH), GxP proficiency (GLP/GCP/GMP), program-level risk management, cross-functional leadership without direct authority
Preferred skills
Experience in fast-paced biotech transitioning from early-stage to commercial, fluency with data-driven teams and automation tools, first-principles thinking
Technologies
AI-enabled technology platforms, real-world data tools, digital compliance frameworks
Responsibilities
Embed Quality by Design principles into clinical, nonclinical, and CMC development plans; Proactively identify quality risks and establish mitigation strategies for assigned Asset Pods; Assess quality health of external target assets during in-licensing due diligence; Drive audit-readiness strategy for commercial launch or out-licensing; Interpret global regulatory expectations to build lean compliance frameworks
Seniority
Senior Director, strategy & mentorship
