Director/Senior Director of Asset Quality Assurance

About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others. You can read more at the following links: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently. About the Position Formation Bio is an AI native Biotech company running drug development programs, and the Quality function here is built to match that operating model: lean, risk-calibrated, and embedded in asset decisions from day one. You will not be maintaining a compliance bureaucracy; you will be designing quality frameworks that accelerate programs rather than slow them down. This is a rare seat at the table where quality strategy directly shapes how assets move forward and get to patients. 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. About You You have a proven ability to influence and lead cross-functional Asset Pods and senior stakeholders without direct operational authority. You apply first-principles thinking to bypass rigid compliance mentalities in favor of risk-benefit-based, agile problem solving. You are fluent working with data-driven teams and comfortable leveraging automation and digital tools to maximize data value and process efficiency. You have 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. You have 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. You hold a bachelor’s or advanced degree in a scientific,