Director/Senior Director of Asset Quality Assurance

Director/Senior Director of Asset Quality Assurance responsible for embedding Quality by Design into clinical, nonclinical, and CMC development plans, leading risk and opportunity mapping, performing in-licensing due diligence, and driving acquisition and commercial readiness. Will interpret global regulatory expectations (FDA, EMA, ICH) to build lean, fit-for-purpose compliance frameworks and partner with asset development teams to accelerate programs while ensuring quality and readiness for commercialization. Requires deep GxP proficiency (GLP, GCP, GMP), experience conducting quality due diligence for R&D and early-stage assets, and a proven ability to lead cross-functional teams and engage senior stakeholders; preferred background in AI-enabled drug development and digital data optimization. Total Compensation ranges from $177,500 to $307,000 with additional equity and benefits; location-focused with a hybrid in-office requirement in NYC/Boston areas and consideration for relocation.