James Gaba

About James Gaba

Proven biotechnology leader with over two decades of experience in the global IVD medical devices industry, showcasing expertise in steering quality, QC laboratory operations, technical support and complaint handling-Adaptable leader adept at evolving systems within dynamic business environments, demonstrating a track record of improving and effectively deploying robust laboratory processes and automated solutions-Accomplished mentor and team builder, leading by example to cultivate high-performing teams that drive organizational success-A staunch advocate for lean concepts, continuous improvement (CI), and operational excellence, with a focus on elevating organizational efficiency and effectiveness.

Experience

1. Associate Director of Quality Control

   Illumina

   Jun 2022 — Present · San Diego, CA, US

   Orchestrates strategic planning initiatives for QC operations aimed at growth initiatives, productivity and efficiency. Facilitates seamless QC method transfers from development to operations, and from site to site-Champions the servant leadership model to foster team-based culture, emphasizing the value of self-directed work teams and high performance work teams-Leads efforts to align QC functions globally across business regions, ensuring cohesion and efficiency in operations spanning the Americas (AMR) and Asia-Pacific (APJ)-Oversee resource allocation from projects and initiatives, including New Product Introduction (NPI) test method transfers and continuous improvement efforts, optimizing effectiveness-Manages a cost center with substantial annual budget, exercising financial stewardship with an estimated $16M annual allocation.

Education

• Johns Hopkins University Advanced Academic Programs

  Master of Science - MS, Regulatory Science

  2026

• University of Phoenix

  Master of Business Administration (M.B.A.), Global Management

  2004 — 2006

• UCLA

  B.S., Biology

  1995 — 1999

Skills

• Quality Assurance
• Trend Analysis
• Biotechnology
• Immunoassays
• Validation
• Lims
• Quality System
• V&V
• Glp
• 21 Cfr Part 820
• Regulatory Affairs
• Lifesciences
• Quality Management
• Calibration
• Elisa
• Continuous Improvement
• 21 Cfr
• Problem Solving
• Lean Manufacturing
• Process Improvement
• Quality Control
• Technology Transfer
• Gmp
• Hplc
• Ivd
• Design Control
• Autoimmunity
• Iso
• In Vitro Diagnostics
• Pharmaceutical Industry
• Sop
• Fda
• Testing
• Medical Devices
• Technical Services
• Capa
• Software Documentation
• Cell Culture
• Troubleshooting
• Change Control