Formation Bio
Senior Director of Asset Quality Assurance
$235K–$307K
Boston, MA +3 · Director · Full-time · Posted Jun 5, 2026
- Location
- Boston, MA
New York, NY
116 Huntington Ave., Back Bay, Boston, MA, 02116
16 E 34th St., New York City, NY, 10016 - Education
- Bachelor’s or advanced degree in a scientific, engineering, or related discipline.
About the job
Leads asset-level quality assurance strategy, embedding risk-based quality frameworks across drug development, due diligence, regulatory readiness, and commercialization.
What you'll do
- Integrate Quality by Design into clinical, nonclinical, and CMC development plans, including those using AI-enabled technology and real-world data.
- Assess quality risks and external assets during due diligence, and establish fit-for-purpose controls and mitigations.
- Lead audit-readiness and apply global regulatory expectations to support asset development, commercialization, and strategic transitions.
What they ask for
- Bachelor’s or advanced degree in a scientific, engineering, or related discipline.
- Extensive multidisciplinary GxP experience in biopharma quality assurance leadership, including proficiency across GLP, GCP, and GMP.
- Experience conducting quality due diligence for R&D and early-stage clinical assets, and knowledge of commercialization inspections, product launch, and post-approval commitments.
- Track record managing program-level risk frameworks and leading assets through major regulatory inflection points and strategic transactions.
Nice to have
- Experience at a fast-paced biotech that has transitioned from early-stage to commercial.
Pay
$235,000 - $307,000 (USD, total pay)
Tools
AI-enabled technology, real-world data, FDA, EMA, ICH, GLP, GCP, GMP
AI focus
Applies quality frameworks and regulatory expectations to AI-enabled drug development and digital environments.
Model-written summary · the original posting is authoritative