About the Operational Learning Institute

Jim Ball has spent 20+ years at the intersection of operations, human performance, and organizational learning — not as a consultant observing from the outside, but as a practitioner responsible for the results.

At Genentech, Jim led a cross-functional investigation into contamination discovered across 21 released batches representing $2.6 billion in finished drug product. He conducted a three-year retrospective production data review, performed chemical characterization and toxicity analysis, and personally defended product quality to regulators during FDA and EMA inspections — achieving a 95% success rate in keeping affected products on the market.

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At Lonza Biologics, Jim led a 101-person cGMP production department while simultaneously driving organizational development across a 1,000-person facility — achieving a 40% reduction in deviations per batch and 13 zero-deviation batches in a single year.

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At Takeda Pharmaceuticals, Jim served as Head of Human Performance, Operational Improvement & Business Transformation — leading a 34-person department responsible for investigations, CAPA, change control, and continuous improvement across a 900-person manufacturing organization. He designed and delivered the Investigator Certification Program that certified 40 investigators, achieved 30-day deviation record closure, and contributed to Takeda's first observation-free FDA audit in 2024.

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Jim founded the Operational Learning Institute to bring that same methodology — proven in some of the most demanding regulated environments in the world — to a broader audience of investigators, quality professionals, and operations leaders who want to do better work.