Director of IT & GxP Systems — Biotech

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

Benefits offered by this job

Comprehensive benefits

Job summary

Lakefront Biotherapeutics is seeking a Director of IT to lead day-to-day technology operations, owning end-user services, business application support, and GxP validation programs. This role works closely with Quality, Regulatory Affairs, CMC, Manufacturing, and Clinical Operations to ensure inspection readiness and data integrity.

The successful candidate will manage MSPs and vendors, drive the IT roadmap with the VP of IT, and ensure 21 CFR Part 11, EU Annex 11, and GAMP 5 compliance across

Qualifications

• Bachelor’s degree in information technology, computer science, or a related field.
• 10+ years in IT, including at least 4 years in a lead or management role.
• At least 5 years supporting biotech, pharmaceutical, or FDA-regulated life sciences company.
• Hands-on experience with CSV or CSA, 21 CFR Part 11, and GxP documentation practices.
• Experience supporting GxP systems in manufacturing and laboratory settings (GMP and GLP).
• Hands-on experience administering or implementing Veeva Vault in support of Quality and Regulatory functions.

Responsibilities

• Lead IT operations, end-user services, and application support.
• Partner with Facilities on lab/office build-outs and IT requirements.
• Maintain CSV/CSA programs and ensure 21 CFR Part 11 and EU Annex 11 compliance.
• Oversee business applications portfolio (Vault, ERP, HRIS, etc.) and data integration.
• Plan IT strategy with VP of IT and manage budgets, contracts, and staff growth.

Skills

Leadership & management

Veeva Vault

Cloud & SaaS platforms

MSP/vendor management

GxP compliance basics

Regulatory/auditor communication

IT budgeting & contracts

Education

Bachelor’s degree in IT, CS, or related field

Tools

Veeva Vault

ERP systems

Job description

Lakefront Biotherapeutics is seeking a Director of IT to lead day-to-day technology operations, owning end-user services, business application support, and GxP validation programs. This role works closely with Quality, Regulatory Affairs, CMC, Manufacturing, and Clinical Operations to ensure inspection readiness and data integrity.

The successful candidate will manage MSPs and vendors, drive the IT roadmap with the VP of IT, and ensure 21 CFR Part 11, EU Annex 11, and GAMP 5 compliance across