Director/Senior Director of Asset Quality Assurance (AI Biotech)

Location: Hybrid, requiring 3 days per week in office in the Boston or New York City metro areas. Applicants in the Research Triangle, NC, and San Francisco Bay Area may also be considered. Apply only if you reside in these locations or are willing to relocate.

Salary: Director: $177,500–$232,000 annually; Senior Director: $235,000–$307,000 annually, plus equity and benefits.

Company

hirify.global is an AI-driven biopharma company developing technology, processes, and capabilities to accelerate drug development and clinical trials.

What you will do

• Embed Quality by Design principles into clinical, nonclinical, and CMC development plans, including programs using AI-enabled technology and real-world data.
• Identify quality risks and opportunities within Asset Pods and establish fit-for-purpose controls and mitigation strategies with technical and strategic experts.
• Assess the quality health, data reliability, compliance risks, and vendor footprint of external assets during in-licensing and due diligence.
• Develop audit-readiness strategies to support transitions from development to commercial launch or out-licensing.
• Interpret FDA, EMA, and ICH expectations for digital and AI-accelerated environments and build lean compliance frameworks.

Requirements

• Proven ability to influence and lead cross-functional Asset Pods and senior stakeholders without direct operational authority.
• Deep knowledge of asset transitions from preclinical and clinical development through commercialization or acquisition readiness.
• Well-rounded GxP experience across GLP, GCP, and GMP, with leadership experience in biopharma quality assurance.
• Experience conducting quality due diligence for R&D and early-stage clinical assets.
• Understanding of commercialization inspections, product launches, and post-approval commitments.
• Bachelor’s or advanced degree in a scientific, engineering, or related discipline, plus experience managing program-level risk frameworks and regulatory inflection points.

Culture & Benefits

• Lean, risk-calibrated quality function embedded in asset development and decision-making.
• Risk-benefit-based and agile approach rather than rigid compliance bureaucracy.
• Equity, comprehensive benefits, and generous perks.
• Hybrid work model centered on key U.S. biopharma hubs.