Associate Director, GMP Quality

Location: Hybrid, requiring 3 days per week in the 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. Applicants must reside in these locations or be willing to relocate.

Total compensation: $161,500–$202,000 per year, plus equity, comprehensive benefits, and perks.

Company

hirify.global is a technology- and AI-driven pharmaceutical company developing medicines more efficiently through technology platforms, partnerships, and clinical development capabilities.

What you will do

• Ensure GMP compliance with FDA, EMA, ICH, and internal procedures across manufacturing, testing, packaging, labeling, storage, and distribution.
• Review and approve SOPs, master batch records, specifications, protocols, reports, executed batch records, and testing results.
• Support batch disposition and investigations into deviations, OOS/OOT results, environmental monitoring excursions, and other quality events.
• Audit and qualify suppliers, CDMOs, laboratories, and service providers, and maintain Quality Agreements.
• Support regulatory inspections and due diligence audits while applying risk management principles such as FMEA.
• Identify opportunities to use AI to improve quality assurance efficiency, compliance, and decision-making.

Requirements

• Bachelor’s degree in Chemistry, Biology, Engineering, Pharmaceutical Sciences, or another scientific discipline.
• Minimum 10 years of experience in pharmaceutical GMP Quality Assurance.
• Specific experience with biologics or large-molecule manufacturing and testing.
• Deep understanding of FDA, EMA, and ICH GMP expectations and commitment to patient safety.
• Experience leading investigations, preparing clear documentation, and overseeing CMOs or virtual manufacturing models.
• Strong communication, organization, collaboration, accuracy, and adaptability skills.

Culture & Benefits

• Hybrid work environment with regular office attendance.
• Equity compensation in addition to base salary.
• Comprehensive benefits and generous perks.
• Focus on quality, transparency, continuous improvement, and faster drug development.