The Role

The Director of IT runs day-to-day technology operations for Lakefront Bio and leads delivery of the IT roadmap set with the Vice President of IT. This is a hands-on leadership role. You will own end-user services, business application support, and the compliance posture of our systems. You will manage managed service providers (MSPs) and vendors, and you will make sure our GxP-relevant systems stay validated and inspection-ready.

You will work closely with Quality, Regulatory Affairs, CMC and manufacturing, Research and laboratory operations, Clinical Operations, Facilities, and Finance. The right person is comfortable troubleshooting a user escalation in the morning and presenting a validation plan to Quality in the afternoon.

What You'll Do

IT OPERATIONS AND SERVICE DELIVERY

• Manage MSPs, Contractors and IT vendors against defined SLAs, including help desk, onboarding and offboarding, and asset lifecycle.
• Set service standards for end-user support and measure performance against them for your defined location.
• Help to set that standards for service delivery related to ticket queue creations and KPI metrics reporting.

FACILITIES PARTNERSHIP

• Work closely with Facilities on lab and office build-outs, renovations, expansions, and site moves, including IT requirements gathering and user readiness.
• Support building technology systems with Facilities, such as badge access control, conference room AV, and visitor management.
• Coordinate support for lab instruments and lab equipment monitoring systems (for example, freezer and environmental monitoring).

GXP SYSTEMS AND COMPLIANCE

• Partner with Quality to maintain a risk-based computer system validation (CSV) or computer software assurance (CSA) program aligned with GAMP 5.
• Make sure GxP systems meet 21 CFR Part 11 and EU Annex 11 requirements for electronic records, electronic signatures, audit trails, and access control.
• Support GxP systems across manufacturing and laboratory operations (GMP and GLP), including CMC and external manufacturing systems, batch and production records, laboratory data systems, and instrument-generated records.
• Maintain data integrity practices (ALCOA+) across clinical, manufacturing, and laboratory records, including audit trail review and controlled review and approval workflows.
• Own IT SOPs for change control, access reviews, and periodic system review.
• Represent IT during regulatory inspections, sponsor audits, and vendor qualification audits.

BUSINESS APPLICATIONS

• Own the Veeva Vault platform as a core system of record, including Vault QualityDocs and QMS (document control, change control, deviations, CAPA, and training) and Vault RIM (submissions, registrations, and health authority correspondence).
• Partner with Quality and Regulatory Affairs on Vault configuration, lifecycle and workflow design, document and object migrations, release management, and periodic Vault releases.
• Lead selection, implementation, and support of the wider application portfolio, including eTMF, ELN/LIMS and other laboratory informatics, manufacturing and supply chain systems, ERP and finance tools, and HRIS.
• Coordinate data exchange with CROs, CDMOs, central labs, and other external partners, including controlled exchange of GxP manufacturing and laboratory records.
• Manage integrations, user access, and license use across the application portfolio.

LEADERSHIP AND PLANNING

• Help the VP of IT build the IT strategy, roadmap, and annual budget, then own execution.
• Track IT spend, contracts, and renewals, and find savings where they exist.
• Manage and develop [0–2] IT staff as the team grows.
• Write clear policies and user guidance, and report on service and project status to leadership.

What You Bring

REQUIRED

• 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), 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.

PREFERRED

• 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.

Base compensation for this position ranges from $230,000 - $250,000. Actual base compensation will be determined based on a variety of factors including experience, qualifications, job-related knowledge, demonstrated skills and geographic location. The company reserves the right to modify base salary ranges at any time. In addition, this position is eligible for participation in Lakefront Biotherapeutics’ performance bonus plan. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.