Operations consulting for regulated manufacturers, led personally from diagnosis to handoff.
I work with medical device, biotech, pharmaceutical and precision manufacturers on the operational problems that cost the most when they go wrong: held revenue, stalled launches, chronic service failures and initiatives that never quite land. Every engagement is led by me personally, from diagnosis through handoff.
Lean Six Sigma & operational excellence
Black Belt-led improvement on lead time, stockouts, yield and variation, grounded in statistics and plant-floor reality.
Product transfer & NPI
New product introduction, design transfer, site-to-site and supplier transfers, and manufacturing readiness for launch.
PMO, portfolio governance & interim Chief of Staff
Portfolio prioritization, steering committees, operating rhythm and executive reporting, or a hands-on interim Chief of Staff for an operations leader.
Digital manufacturing & practical AI
Turning manufacturing data and KPIs into better decisions, and choosing AI use cases that pay back in measurable operating value.
FDA 483 & quality remediation
Program leadership for recovery after FDA 483 observations, product holds and sterilization or validation issues, built to get product shipping again and keep it shipping.
Ways to engage
- Fixed-scope project: a defined problem, plan and result, such as a lead-time reduction or a product transfer.
- Advisory retainer: ongoing support for an operations or quality leader.
- Interim leadership: program lead, PMO lead or Chief of Staff for a set period.
