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About the Role

Formation Bio is an AI-native Biotech company running drug development programs. The Quality function is designed to be lean, risk-calibrated, and embedded in asset decisions from day one, focusing on designing quality frameworks that accelerate programs rather than slow them down. This role offers a unique opportunity to directly shape quality strategy and influence how assets move forward to patients.

Responsibilities

• Integrate Quality by Design principles into clinical, nonclinical, and CMC development plans, including those leveraging AI-enabled technology and real-world data.
• Proactively identify quality risks and opportunities within assigned Asset Pods and establish fit-for-purpose control and mitigation strategies.
• Assess the quality health of external target assets during due diligence, including data quality, compliance risks, and vendor footprint.
• Drive the audit-readiness strategy to ensure seamless transition of assets toward commercial launch or out-licensing.
• Interpret and apply global regulatory expectations in digital and AI-accelerated environments to build 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 for risk-benefit-based, agile problem solving.
• Fluent working with data-driven teams and comfortable leveraging automation and digital tools.
• Deep knowledge of critical asset transitions from preclinical to commercial readiness, with GxP proficiency across GLP, GCP, and GMP.
• Demonstrated skill in conducting quality due diligence assessments for R&D and early-stage clinical assets.
• Deep understanding of requirements for commercialization inspections, product launch, and post-approval commitments.
• Proven track record of managing program-level risk management frameworks.
• Successfully led assets through major regulatory inflection points and strategic transactions.

Skills

• Quality by Design (QbD)
• Risk Management
• Due Diligence
• Audit Readiness
• Regulatory Intelligence
• AI-enabled technology
• Real-world data
• GLP
• GCP
• GMP

Location

• New York City metro area
• Boston metro area
• Research Triangle (NC)
• San Francisco Bay Area

Work Type

• Hybrid

Experience Level

• Director
• Senior Director

Education Level

• Bachelor’s or advanced degree in a scientific, engineering, or related discipline

Salary/Compensations

• Director $177,500 - $222,000
• Senior Director $235,000-293,500

Benefits

• Equity
• Comprehensive benefits
• Generous perks

About the Company

• Formation Bio is a tech and AI driven pharma company focused on efficient drug development.
• Founded in 2016 as TrialSpark Inc., the company has built technology platforms, processes, and capabilities to accelerate drug development and clinical trials.
• Formation Bio partners, acquires, or in-licenses drugs to develop programs past clinical proof of concept and beyond.
• The company is backed by investors including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others.

Equal Opportunity

• Formation Bio is committed to building a diverse and inclusive team.
• We are an equal opportunity employer and welcome candidates from all backgrounds.
• All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.