Director of Asset Quality Assurance

Responsibilities

• Embed Quality by Design (QbD): Partner with asset development teams upstream to integrate Quality by Design principles into clinical, nonclinical, and CMC development plans, including those leveraging AI-enabled technology and real-world data.
• Risk & Opportunity Mapping: Proactively identify meaningful quality risks and opportunities within assigned Asset Pods and collaborate with technical and strategic subject matter experts to establish fit-for-purpose control and mitigation strategies.
• In-Licensing & Asset Due Diligence: Assess the quality health of external target assets during due diligence, including data quality and reliability, compliance risks, and vendor footprint.
• Acquisition & Commercial Readiness: Drive the audit-readiness strategy to ensure assets transition seamlessly from development toward commercial launch or out-licensing.
• Regulatory & Audit Intelligence: Interpret and apply global regulatory expectations (FDA, EMA, ICH) in digital and AI-accelerated environments, applying first-principles thinking to build fit-for-purpose, lean compliance frameworks for asset development and commercialization.

Requirements

• Proven ability to influence and lead cross-functional Asset Pods and senior stakeholders without direct operational authority.
• Apply first-principles thinking to bypass rigid compliance mentalities in favor of risk-benefit-based, agile problem solving.
• Fluent working with data-driven teams and comfortable leveraging automation and digital tools to maximize data value and process efficiency.
• Deep knowledge of the critical transitions an asset makes between preclinical and clinical phases through commercial or acquisition readiness, with well-rounded GxP proficiency across GLP, GCP, and GMP.
• Demonstrated skill in conducting quality due diligence assessments for R&D and early-stage clinical assets, and a deep understanding of requirements for commercialization inspections, product launch, and post-approval commitments.
• Bachelor’s or advanced degree in a scientific, engineering, or related discipline, with extensive multidisciplinary GxP experience in biopharma quality assurance leadership, ideally within a fast-paced biotech that has successfully transitioned from early-stage to commercial.
• Proven track record of managing program-level risk management frameworks and successfully leading assets through major regulatory inflection points and strategic transactions.