Associate Director/Director, Digital Quality (AI)

Location: Hybrid, requiring 3 days per week in office in the Boston or New York City metro areas; applicants from the Research Triangle, NC, and San Francisco Bay Area may also be considered. Candidates must reside in these locations or be willing to relocate.

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

Company

hirify.global is a technology- and AI-driven pharmaceutical company developing platforms and capabilities to accelerate drug development and clinical trials.

What you will do

• Own R&D Data and Records Integrity processes and serve as Business Owner for Veeva Quality Docs and DocuSign Part 11.
• Build and maintain the R&D data governance framework, including data inventories, stewardship, retention, access controls, and risk assessments.
• Oversee AI applications used across R&D, including context-of-use assessments, model reviews, human accountability, and ongoing control monitoring.
• Lead cross-functional data migration, asset onboarding, digitization, and system change initiatives.
• Establish guardrails for AI use in QMS activities such as investigation drafting, CAPA analysis, and audit preparation.
• Support audits, vendor qualification, inspection readiness, Quality Events, Investigations, and CAPA approvals.

Requirements

• 7+ years of experience for Associate Director or 10+ years for Director in GxP quality assurance, data integrity, or computerized systems compliance within pharma, biotech, or a related regulated industry.
• Bachelor’s degree in a scientific, engineering, information systems, or related discipline.
• Strong knowledge of data integrity principles, including ALCOA+, and applicable GMP, GCP, and/or GLP regulations.
• Experience with computer system assurance and validation using risk-based approaches to context-of-use and functionality changes.
• Working knowledge of AI/ML risk concepts, including model validation, bias, explainability, and drift monitoring.
• Experience with R&D data governance, AI application oversight, Process or System/Business Ownership, SOP governance, KPI monitoring, and change control.

Culture & Benefits

• Work directly with the Head of Quality without an intermediate management layer.
• Collaborate with R&D, IT, Operational Excellence, vendors, and regulatory stakeholders.
• Receive equity, comprehensive benefits, and generous perks.
• Work within a mission focused on accelerating access to new medicines through more efficient drug development.