Lakefrontbiotherapeuticsinc
Director, IT
South San Francisco, CA. Posted a month ago
The role
The Director of IT runs day-to-day technology operations and leads the delivery of the IT roadmap. This hands-on leadership role owns end-user services, business application support, and the compliance posture of systems.
What you will do
- Manage MSPs, Contractors and IT vendors against defined SLAs
- Set service standards for end-user support
- Work with Facilities on lab and office build-outs, renovations, expansions, and site moves
- Support building technology systems such as badge access control, conference room AV, and visitor management
- Coordinate support for lab instruments and lab equipment monitoring systems
- Partner with Quality to maintain a risk-based CSV or CSA program
- Ensure GxP systems meet 21 CFR Part 11 and EU Annex 11 requirements
- Support GxP systems across manufacturing and laboratory operations
- Maintain data integrity practices across clinical, manufacturing, and laboratory records
- Own the Veeva Vault platform as a core system of record
Required qualifications
- Bachelor's degree in information technology, computer science, or a related field, or equivalent experience
- 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)
- 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
Nice to have
- Experience at a clinical-stage company preparing for late-stage trials, an NDA or BLA submission, or commercial launch
- Veeva Vault certification, or implementation experience across multiple Vault applications (QualityDocs, QMS, RIM, eTMF)
- Experience with GxP systems supporting external manufacturing partners, including CDMO and contract laboratory data exchange
- Experience supporting an IPO, SOX implementation, or ITGC audits
- Certifications such as ITIL or relevant Microsoft credentials
- Familiarity with lab informatics and instrument data management
Benefits
- Comprehensive and generous benefits and programs
About the company
Lakefront Biotherapeutics is a global biotech with offices in Belgium, Chicago and San Francisco, focused on building a differentiated immunology and inflammation pipeline. The company operates with small, empowered teams that work hands-on across development stages.