Formation Bio

Formation Bio

Senior Director of Asset Quality Assurance

Boston, MA; New York, NY · Director

Sponsorship not specified$235k-$307kDetected 2 days ago
GCPSparkFDA RegulatoryResearchAnimal StudiesLeadershipCommunicationGxP

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odds of building a lasting career here

59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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About the role

  • About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.
  • 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.
  • 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.

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.
  • 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.
  • 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.
  • 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.
  • Drive the audit-readiness strategy to ensure assets transition seamlessly from development toward commercial launch or out-licensing.
  • 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.

Nice to have

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

Skills

  • Our Vision for AI in Pharma
  • Our Current Drug Portfolio
  • Our Technology & Platform

Compensation

  • Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience.
  • In addition to base salary, we offer equity, comprehensive benefits, and generous perks.
  • $235,000 - $307,000

Benefits

  • 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.
  • You apply first-principles thinking to bypass rigid compliance mentalities in favor of risk-benefit-based, agile problem solving.

Company info

  • 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.
  • We are an equal opportunity employer and welcome candidates from all backgrounds.

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.
  • 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.
  • Formation Bio is committed to building a diverse and inclusive team.
  • 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.
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