Executive Director, Research & Development Quality Assurance (GxP)

Location: Cambridge, Massachusetts, United States; 70% in-office work model. Only individuals who qualify as U.S. persons are eligible due to U.S. export control requirements.

Salary: $224,900–$404,600 annually, with potential bonus, incentive compensation, or equity.

Company

hirify.global develops mRNA medicines through a technology platform and a broad biopharmaceutical development pipeline.

What you will do

• Set the global R&D Quality Assurance strategy, governance model, and operational excellence framework across GCP, GLP, GCLP, and GVP.
• Provide quality oversight and serve as a strategic partner to Clinical Development, Pharmacovigilance, Non-Clinical Development, Toxicology, and Research.
• Embed risk-based quality management into study design, data generation, vendor oversight, and the full R&D lifecycle.
• Lead global regulatory inspection readiness and act as inspection host for FDA, EMA, and MHRA inspections.
• Build and lead a high-performing R&D QA organization and strengthen a data-driven quality culture.
• Own quality metrics, deviations, CAPAs, issue management, regulatory intelligence, the GVP Quality System, and R&D QMS effectiveness.

Requirements

• Bachelor’s degree in life science or a related field; an advanced degree is preferred.
• 15+ years of progressive biopharmaceutical experience with deep expertise in GCP, GLP, GCLP, and GVP.
• 10+ years leading multifunctional R&D quality organizations, including budgets, staffing, resource allocation, and continuous improvement.
• Experience developing global audit programs and hosting health authority inspections.
• Extensive knowledge of FDA, EMA, MHRA, PMDA, ICH, EU pharmacovigilance regulations, ICH E2, EU PV legislation, and ICH E6 (R3).
• U.S. person status is required; non-U.S. persons cannot be sponsored for an export control license.

Culture & Benefits

• In-person collaboration supported by a 70/30 work model.
• Healthcare coverage and voluntary benefits.
• Fitness, mindfulness, and mental health resources.
• Family planning support, including fertility, adoption, and surrogacy benefits.
• Paid vacation, volunteer days, sabbatical, recharge days, and year-end shutdown.
• Savings and investment opportunities, plus location-specific benefits.