Biotech IT Director: GxP, Vault & Compliance Lead

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

Benefits offered by this job

Performance bonus

Comprehensive benefits

Job summary

Lakefront Biotherapeutics, Inc. is seeking a Director of IT to run day-to-day technology operations and deliver the IT roadmap with the VP of IT. This hands-on leader will own end‑user services, business applications, and GxP system validation readiness.

You will collaborate with Quality, Regulatory, CMC, manufacturing, and other functions, ensuring systems stay validated and inspection-ready while managing MSPs, vendors, and budgets.

Qualifications

• Bachelor’s degree in information technology or related field or equivalent experience.
• 10+ years in IT with 4+ years in a lead/management role.
• 5+ years supporting biotech or FDA-regulated life sciences environments.

Responsibilities

• Oversee IT operations, end-user services, and vendor management against SLAs.
• Partner with Facilities on lab/office builds and IT requirements.
• Maintain CSV/CSA programs with GxP compliance and 21 CFR Part 11 alignment.
• Lead selection, deployment, and support of Vault QMS, Vault RIM, and related apps.
• Coordinate data exchange with CROs, CDMOs, and external partners.
• Manage IT staff growth and report status to leadership.

Skills

IT leadership

CSV/CSA

GxP documentation

Veeva Vault

Cloud & SaaS

Vendor management

Budget management

Cross-functional communication

Education

Bachelor’s degree in information technology or related field

Tools

Veeva Vault

ERP

LIMS/ELN

Job description

Lakefront Biotherapeutics, Inc. is seeking a Director of IT to run day-to-day technology operations and deliver the IT roadmap with the VP of IT. This hands-on leader will own end‑user services, business applications, and GxP system validation readiness.

You will collaborate with Quality, Regulatory, CMC, manufacturing, and other functions, ensuring systems stay validated and inspection-ready while managing MSPs, vendors, and budgets.