Senior Director: Quality by Design & Asset Readiness

Formation Bio; New York (NY); Hybrid; USD 177,500 - 307,000; Full time

Benefits offered by this job

Equity

Comprehensive benefits

Generous perks

Job summary

Formation Bio, an AI native Biotech in New York, is seeking a Director or Senior Director of Quality to influence and lead quality strategies in drug development programs. The role emphasizes embedding Quality by Design principles and regulatory compliance throughout the asset lifecycle.

The ideal candidate will have extensive GxP experience, proven leadership in cross-functional teams, and the ability to integrate risk management into processes. This position offers a total compensation range between $177,500 and $307,000, with equity and comprehensive benefits.

Qualifications

• Proven ability to influence and lead cross-functional teams.
• Experience in quality due diligence assessments.
• Deep knowledge of GxP across GLP, GCP, and GMP.

Responsibilities

• Embed Quality by Design principles into development plans.
• Proactively identify quality risks and opportunities.
• Drive audit-readiness strategy for asset transitions.

Skills

Cross-functional leadership

Risk management

Regulatory knowledge (FDA, EMA, ICH)

Data-driven decision making

Quality assurance expertise (GxP)

Education

Bachelor’s or advanced degree in a scientific or engineering discipline

Tools

Digital compliance frameworks

Job description

Formation Bio, an AI native Biotech in New York, is seeking a Director or Senior Director of Quality to influence and lead quality strategies in drug development programs. The role emphasizes embedding Quality by Design principles and regulatory compliance throughout the asset lifecycle.

The ideal candidate will have extensive GxP experience, proven leadership in cross-functional teams, and the ability to integrate risk management into processes. This position offers a total compensation range between $177,500 and $307,000, with equity and comprehensive benefits.