Senior Director of Asset Quality Assurance

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, 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.
• You have a proven track record of managing program-level risk management frameworks and successfully leading assets through major regulatory inflection points and strategic transactions.

Pay and benefits

Compensation Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive benefits, and generous perks. If the posted range doesn't match your expectations, we still encourage you to apply!

Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate.

We've seen a rise in recruiting impersonation scams across the industry, where fake profiles pose as recruiters aiming to trick candidates into sharing personal and financial information through illegitimate interviews and job offers. All legitimate recruiting communications from Formation Bio will come from a @formation.bio email address. If you receive outreach from someone claiming to work at Formation Bio through any other domain or channel, please disregard it and do not share any personal information.