Summary
Overview
Work History
Education
Skills
Accomplishments
Affiliations
Timeline
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Stacey Barnes

Castro Valley

Summary

Technology executive with 25+ years of experience leading digital strategy, enterprise technology, and business transformation for emerging and global life sciences organizations. Proven success building scalable technology organizations that enable companies to progress from early clinical development through commercial readiness while balancing startup agility with the rigor of regulated operations.

Trusted advisor to executive leadership, partnering across Commercial, Manufacturing, Regulatory Affairs, Quality, Finance, Clinical Operations, and Technical Operations to align technology investments with strategic business objectives. Recognized for developing pragmatic, right-sized technology strategies that accelerate growth, improve operational maturity, reduce risk, and support commercialization.

Expertise includes digital strategy, enterprise architecture, ERP, CRM, quality systems, manufacturing technology, cybersecurity, infrastructure, AI governance, GxP compliance, and organizational leadership.

Overview

2027
2027
years of professional experience

Work History

Head of Information Technology

Kyverna Therapeutics
01.2024 - 07.2026

Clinical-stage cell therapy biotechnology company advancing toward commercial readiness.

Commercial Strategy & Business Transformation

  • Developed the enterprise technology strategy supporting Kyverna's transition from clinical-stage biotechnology company to commercial readiness.
  • Partnered with Executive Leadership to align technology investments with manufacturing, regulatory, quality, commercial, and corporate priorities.
  • Created multi-year technology roadmaps balancing rapid organizational growth with disciplined investment and regulatory compliance.
  • Served as strategic advisor on technology decisions supporting commercialization, operational scalability, and enterprise risk management.

Digital Strategy & Enterprise Architecture

  • Developed the Kyverse enterprise digital strategy establishing a scalable architecture supporting future commercial operations.
  • Designed enterprise integration strategy connecting ERP, CRM, Manufacturing, Quality, Clinical, Regulatory, and Commercial platforms.
  • Championed composable architecture and low-code solutions that improved business agility while reducing software costs.
  • Established enterprise governance for technology investments, portfolio prioritization, and executive decision making.

Commercial Readiness

  • Led technology strategy supporting Commercial, Manufacturing, Supply Chain, Regulatory Affairs, Finance, and Quality organizations.
  • Directed evaluation and implementation planning for commercial technology platforms supporting patient enrollment, reimbursement, scheduling, manufacturing, fulfillment, and customer engagement.
  • Partnered with Commercial leadership to develop an integrated digital ecosystem supporting future launch operations.
  • Balanced implementation timelines with BLA milestones, organizational readiness, and long-term scalability.

Regulatory, Quality & Compliance

  • Directed technology initiatives supporting FDA inspection readiness and Biologics License Application (BLA) activities.
  • Oversaw governance of GxP systems supporting Quality, Manufacturing, Technical Operations, and Regulatory Affairs.
  • Led cybersecurity strategy, SOX IT General Controls, IT compliance, and enterprise technology risk management.
  • Partnered closely with Quality and Regulatory organizations to ensure technology enabled inspection readiness and commercialization objectives.

Leadership

  • Built and led Infrastructure, Cybersecurity, Enterprise Applications, Data, Compliance, and PMO organizations.
  • Managed multimillion-dollar technology budgets and strategic vendor relationships.
  • Established governance processes improving executive visibility into technology investments, project execution, and business outcomes.
  • Fostered a collaborative technology organization focused on business partnership, operational excellence, and innovation.

Head of Information Technology

Nutcracker Therapeutics
09.2020 - 01.2024
  • Built the company's first enterprise IT organization supporting rapid organizational growth.
  • Developed enterprise technology strategy aligned with manufacturing, research, and corporate objectives.
  • Successfully implemented validated GxP platforms including Sage X3 ERP, TrackWise Digital (QMS, DMS, TMS), and Nuvolo CMMS.
  • Established IT governance, cybersecurity, infrastructure, and managed services supporting a rapidly growing workforce.
  • Partnered across Operations, Manufacturing, Quality, Finance, and Research to build scalable technology capabilities.

Head of Information Technology

FormFactor, Inc
10.2006 - 09.2020

Progressively promoted through executive leadership positions overseeing enterprise applications, infrastructure, cybersecurity, PMO, and global IT operations supporting more than 1,800 employees worldwide.

Selected accomplishments:

  • Directed a $17 million enterprise transformation modernizing core business systems across Finance, Supply Chain, HR, Sales, and Manufacturing.
  • Implemented Oracle ERP, Oracle HCM, Oracle CPQ, Oracle EPBCS, Oracle GTM, and enterprise integrations.
  • Reduced annual IT operating expenses by $3.2 million through strategic portfolio optimization.
  • Presented enterprise technology strategy and investment roadmaps to Executive Leadership and Board of Directors.
  • Built enterprise security strategy and governance supporting global operations.
  • Established IT policies and procedures resulting in 100% successful SOX audits with no material weaknesses or deficiencies.

Earlier Career

Various
  • Sephora — eCommerce Project Manager
  • Terrace Consulting — Product Group Manager
  • The Doctors Company — Manager, Business Systems Analysis
  • Terrace Consulting — Consulting Manager
  • Pacific Gas & Electric — Analyst Programmer

Education

Bachelor of Science - Management Information Systems

California Polytechnic State University
San Luis Obispo

Skills

Executive Leadership Technology Strategy Digital Transformation Commercial Launch Organizational Leadership Portfolio Governance Executive Communications Board Presentations Fractional CIO Leadership

Life Sciences Cell & Gene Therapy Commercial Readiness GxP Compliance FDA Inspection Readiness BLA Support Quality Systems Manufacturing Technology Regulatory Operations

Enterprise Platforms ERP CRM eQMS Cell Orchestration Data Platforms Enterprise Integration Identity & Access Management

Technology Enterprise Architecture Cloud Infrastructure Cybersecurity AI Governance Low-Code Platforms Data Governance Infrastructure Modernization

Accomplishments

  • More than 25 years leading enterprise technology organizations across biotechnology and high-tech manufacturing
  • Built technology organizations supporting companies from startup through commercial readiness
  • Executive technology advisor partnering with CEOs, CFOs, COOs, and Executive Leadership Teams
  • Led multimillion-dollar enterprise transformation initiatives and strategic technology investments
  • Extensive experience supporting GxP operations, FDA inspection readiness, and commercialization planning
  • Built and led high-performing Infrastructure, Security, Enterprise Applications, Compliance, PMO, and Data organizations
  • Successfully modernized enterprise application landscapes while improving governance and reducing operating costs

Affiliations

  • Member of the Life Science CIO Community
  • Consortium of Information Systems Executives
  • Project Management Professional

Timeline

Head of Information Technology

Kyverna Therapeutics
01.2024 - 07.2026

Head of Information Technology

Nutcracker Therapeutics
09.2020 - 01.2024

Head of Information Technology

FormFactor, Inc
10.2006 - 09.2020

Earlier Career

Various

Bachelor of Science - Management Information Systems

California Polytechnic State University
Stacey Barnes