Senior Director of Asset Quality Assurance

The role

You will design quality frameworks and integrate Quality by Design principles into clinical, nonclinical, and CMC development plans. You will identify quality risks, conduct due diligence for in-licensing, and drive audit-readiness for asset transitions.

What you will do

• Partner with asset development teams to integrate Quality by Design principles into development plans.
• Identify quality risks and opportunities within assigned Asset Pods.
• Collaborate with subject matter experts to establish control and mitigation strategies.
• Assess the quality health of external target assets during due diligence.
• Drive the audit-readiness strategy for asset transitions toward commercial launch or out-licensing.
• Interpret and apply global regulatory expectations in digital and AI-accelerated environments.

Required qualifications

• Ability to influence and lead cross-functional Asset Pods and senior stakeholders without direct operational authority.
• Ability to apply first-principles thinking for risk-benefit-based, agile problem solving.
• Fluency working with data-driven teams and leveraging automation and digital tools.
• Deep knowledge of transitions between preclinical and clinical phases through commercial or acquisition readiness.
• Well-rounded GxP proficiency across GLP, GCP, and GMP.
• 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.
• Bachelor’s or advanced degree in a scientific, engineering, or related discipline.
• Extensive multidisciplinary GxP experience in biopharma quality assurance leadership.
• Proven track record of managing program-level risk management frameworks.
• Proven track record of leading assets through major regulatory inflection points and strategic transactions.

Nice to have

• Experience within a fast-paced biotech that has successfully transitioned from early-stage to commercial.

Benefits

• Equity
• Comprehensive benefits
• Generous perks

Before you apply

• Please apply only if you reside in New York City, Boston metro areas, Research Triangle (NC), or San Francisco Bay Area or are willing to relocate.

About the company

Formation Bio is a tech and AI driven pharma company that builds technology platforms, processes, and capabilities to accelerate drug development and clinical trials.