Senior Director, IT Compliance & Governance (Biotech)

Location: Remote, United States

Hourly compensation: $122.00–$136.00 per hour, depending on geographical location, experience, skills, and qualifications.

Company

hirify.global is a biotechnology company developing targeted gene therapies using proprietary AAV vectors and its Therapeutic Vector Evolution platform.

What you will do

• Lead IT GxP compliance assessments, remediation plans, evidence readiness, and IT responses for FDA inspections.
• Oversee system validation, periodic reviews, backup and restore testing, change control, SOX ITGC reviews, and access and inventory management.
• Manage the IT Council technology portfolio, including intake, prioritization, risk and value assessment, dependency tracking, status reporting, and escalation.
• Coordinate technology programs supporting BLA submissions, inspections, and commercial launch readiness.
• Coordinate IT governance, procurement, annual planning, budget forecasting, policies, SOPs, and cross-functional operating practices.
• Partner with QA CSV/CSA, Finance Compliance, Legal Compliance, managed services, consultants, and third-party providers.

Requirements

• 15+ years of IT GxP compliance experience, including Part 11, and 12+ years managing or auditing IT operational processes.
• 10+ years developing and maintaining SDLC processes aligned with GAMP 5 principles.
• 8+ years in senior IT leadership within the biotech or pharmaceutical industry.
• Direct experience leading preparation for and responding to an FDA or comparable health authority inspection.
• Experience managing complex IT portfolios with roadmap governance, dependency tracking, executive reporting, vendor coordination, and delivery escalation.
• Bachelor’s degree in life science or computer science; strong knowledge of GxP, SOX, privacy, computer system assurance, data integrity, SDLC, change management, access management, and service continuity.

Nice to have

• Experience with SOX IT general control audits, segregation of duties, and SSAE-18 SOC report reviews.
• Certifications related to GxP, SOX, privacy regulations, IT operations, or project management.
• Experience with Smartsheet, SharePoint, Box, and Veeva Vault.

Culture & Benefits

• Remote work arrangement in the United States.
• Collaborative environment supporting individual contributions and cross-functional work.
• Benefits and opportunities for career development.
• Work is primarily sedentary and performed in typical office or administrative conditions.