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.

Director, IT at Lakefrontbiotherapeuticsinc | JobZoey