Director of Digital Systems Quality Assurance (AI/ML)

Location: Hybrid role based out of the Bridgewater, New Jersey headquarters; remote work most of the time with in-person collaboration and approximately 30% domestic travel.

Salary: $177,000–$242,000 annual

Company

hirify.global is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.

What you will do

• Lead enterprise-level QA oversight for AI/ML solutions across hirify.global’s GxP-regulated digital landscape.
• Develop risk assessments, validation plans, model cards, performance qualification protocols, and ongoing performance monitoring plans.
• Apply GAMP 5, FDA AI/ML guidance, the EU AI Act, Annex 11, and 21 CFR Part 11 to AI/ML quality frameworks.
• Embed responsible AI principles, including bias assessment, human oversight, transparency, data integrity, auditability, explainability, and traceability.
• Govern GenAI and agentic AI use cases, including hallucination risk, non-determinism, prompt governance, and output auditability.
• Support vendor assessments, audits, regulatory inspections, training, SOP development, and cross-functional AI/ML governance.

Requirements

• Bachelor’s degree in life sciences, computer science, data science, engineering, pharmacy, or a related scientific or technical discipline.
• At least 10 years of relevant Quality Assurance experience, including 3–5 years in a Director-level or senior leadership capacity.
• Experience building or contributing to AI/ML quality or validation frameworks in FDA-, EMA-, or similarly regulated environments.
• Hands-on experience with GxP computer system validation or Computer Software Assurance across clinical, manufacturing, laboratory, or commercial domains.
• Knowledge of MLOps, AIOps, model versioning, CI/CD, experiment tracking, drift monitoring, and cloud AI/ML platforms such as Vertex or Bedrock.
• Excellent written and verbal communication, project management, organization, attention to detail, and knowledge of data integrity, 21 CFR Part 11, Annex 11, GAMP 5, SDLC, and CSA.

Nice to have

• Advanced degree such as an MS, MBA, or PhD in a relevant discipline.
• Familiarity with Snowflake and additional AI/ML validation or quality tools.

Culture & Benefits

• Medical, dental, vision, mental health, wellbeing reimbursement, and Employee Assistance Program benefits.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
• Learning programs, LinkedIn Learning, leadership development, mentorship, employee resource groups, and service opportunities.