Director/Senior Director of Asset Quality Assurance

Formation Bio•Boston, NY

69d•Hybrid

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.

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.
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.
Proven track record of managing program-level risk management frameworks and successfully leading assets through major regulatory inflection points and strategic transactions.

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.