Biotech IT Director - GxP & Validation Leader

Lakefront Biotherapeutics; South San Francisco (CA); On-site; USD 230,000 - 250,000; Full time

Benefits offered by this job

Performance bonus

Comprehensive benefits

Career growth opportunities

Job summary

Lakefront Biotherapeutics seeks an experienced Director of IT to run day-to-day technology operations and deliver the IT roadmap with senior leadership. You will own end-user services, business applications, and GxP system validation, while coordinating with Quality, Regulatory, and Manufacturing teams.

You will manage MSPs, vendors, and a growing IT staff, ensuring data integrity and inspection readiness across GMP/GLP environments, with emphasis on Vault configurations and compliance.

Qualifications

• Bachelor’s degree in information technology, computer science, or a related field.
• 10+ years IT experience with 4+ years in a lead or management role.
• 5+ years supporting biotech, pharmaceutical, or FDA-regulated environments.
• Hands-on experience with CSV/CSA, 21 CFR Part 11, and GxP documentation practices.
• Hands-on experience administering or implementing Veeva Vault for Quality/Regulatory.

Responsibilities

• Oversee IT operations and service delivery, including end-user support, SLAs, onboarding/offboarding, and asset lifecycle.
• Partner with Facilities on lab and office build-outs, access control, conference rooms, and equipment monitoring.
• Maintain GxP systems with CSV/CSA programs aligned to GAMP 5 and regulatory expectations.
• Lead business applications portfolio, including Vault, eTMF/LIMS, ERP, HRIS, and data exchanges with partners.
• Help the VP of IT shape strategy, budget, and staffing; report status to leadership and manage vendors.

Skills

Leadership

IT Strategy

GxP Systems

Vendor Management

Regulatory Compliance

Cloud & SaaS

Veeva Vault

Education

Bachelor's degree in IT or related

Tools

Veeva Vault

Cloud Platforms

Job description

Lakefront Biotherapeutics seeks an experienced Director of IT to run day-to-day technology operations and deliver the IT roadmap with senior leadership. You will own end-user services, business applications, and GxP system validation, while coordinating with Quality, Regulatory, and Manufacturing teams.

You will manage MSPs, vendors, and a growing IT staff, ensuring data integrity and inspection readiness across GMP/GLP environments, with emphasis on Vault configurations and compliance.