Director of IT & GxP Operations

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

Job summary

Lakefront Biotherapeutics in San Francisco Bay Area is seeking a Director of IT to lead day-to-day technology operations and deliver the IT roadmap. This hands-on leadership role owns end-user services, business applications, CSV/CSA validation, and GxP compliance across manufacturing and labs.

You will partner with Quality, Regulatory Affairs, CMC, and Facilities to align IT with GxP requirements and data integrity, while managing MSPs, vendors, and the Vault portfolio to enable rapid,

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 another 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), including data integrity expectations for production and laboratory records.
• Hands-on experience administering or implementing Veeva Vault in support of Quality and Regulatory functions.
• Strong working knowledge of cloud and SaaS platforms, identity and access management, and endpoint management.
• Track record of managing MSPs and vendors, contracts, and budgets.
• Experience partnering with Facilities on lab or office build-outs and building systems.
• Clear communication with scientists, clinicians, executives, and auditors alike.

Responsibilities

• IT OPERATIONS AND SERVICE DELIVERY: Manage MSPs, Contractors and IT vendors against defined SLAs, including help desk, onboarding and offboarding, and asset lifecycle.
• FACILITIES PARTNERSHIP: Work closely with Facilities on lab and office build-outs, renovations, expansions, and site moves, including IT requirements gathering and user readiness.
• GXP SYSTEMS AND COMPLIANCE: Partner with Quality to maintain a risk-based CSV/CSA program aligned with GAMP 5 and meet 21 CFR Part 11 / EU Annex 11.
• BUSINESS APPLICATIONS: Own Veeva Vault platform and related QMS/RIM modules; lead expansion to other lab informatics and ERP/HRIS.
• LEADERSHIP AND PLANNING: Help VP of IT build strategy, budget, and roadmaps; manage team growth and report status to leadership.

Skills

Leadership experience

Regulatory/compliance communication

Clear communication with scientists/a?

Education

Bachelor's degree in information technology or related field

Tools

Veeva Vault

Job description

Lakefront Biotherapeutics in San Francisco Bay Area is seeking a Director of IT to lead day-to-day technology operations and deliver the IT roadmap. This hands-on leadership role owns end-user services, business applications, CSV/CSA validation, and GxP compliance across manufacturing and labs.

You will partner with Quality, Regulatory Affairs, CMC, and Facilities to align IT with GxP requirements and data integrity, while managing MSPs, vendors, and the Vault portfolio to enable rapid,