Operational Excellence in Pharma: OEE, Cost of Poor Quality, and Why QMS Investments Underdeliver
Syngene's operational excellence leader on why pharma's QMS and MES investments haven't reduced deviations or improved efficiency — and what the missing intelligence layer looks like.
Vivek Gera Host
Co-founder · Leucine
Gresh Kumar
Head of Operational Excellence · Syngene
About this episode
Vivek Gera (Leucine) sits down with Gresh Kumar, Head of Operational Excellence at Syngene — a CDMO/CRO serving top US and European pharma clients — to unpack why operational excellence has remained on the periphery of pharmaceutical manufacturing despite decades of investment in QMS, MES, and LIMS platforms. Gresh argues that these systems delivered dashboards and data integrity, but never the intelligence layer needed to prevent recurrence or drive efficiency — most investigations still close with "retrain the operator." The episode covers OEE as the manufacturing super-metric, the SQDACC lean daily management framework, and why pharma's intense regulatory focus has inadvertently treated efficiency improvement as a discrete project rather than a continuous stream of observations, the same way quality deviations are tracked batch by batch.
Topics
Key takeaways
- QMS and MES platforms delivered dashboards and data integrity, but not intelligence — most investigations still close with "retrain the operator" because the system cannot surface that the same failure occurred three times in the last two years
- Operational excellence is not a separate organisational pillar — it should be the foundation across manufacturing, quality, R&D, and supply chain, each aligned to the organisation's top-level vision and business objectives
- OEE (Overall Equipment Effectiveness) is the manufacturing super-metric — and the same capital productivity thinking applies in R&D, where reactions-per-setup is a valid efficiency measure
- In pharma, efficiency improvement has been treated as a discrete project reviewed annually, while quality deviations are tracked continuously batch-by-batch — that asymmetry is a structural blind spot
- The SQDACC framework (Safety, Quality, Delivery, Engagement, Compliance, Cost) gives equal weight to efficiency and cost alongside quality — organisations that only speak quality are leaving significant performance on the table
- The missing layer is AI connecting automation to intelligence: the ability to proactively surface past root causes, predict recurrence, and reduce the human investigation burden rather than just tracking deviation counts
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