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Senior Director of Asset Quality AssuranceFormation Bio · Boston, Massachusetts
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Formation Bio

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Senior Director of Asset Quality Assurance

🗓️ Posted 2026-06-05 Boston, Massachusetts Fulltime Hybrid General
💰 Salary US$19,583–US$25,583/mo (US$235,000–US$307,000/yr) 📊 Market US$16,666–US$29,166/mo

About the Company

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.

Requirements

  • ● 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.
  • ● Total Compensation Range: 235,000 - 307,000