Services
Consulting that makes quality work — and last.
Every quality challenge looks a little different, and the right fix depends on your stage, your product, and your team. I work alongside you — not around you — to build systems that hold up to inspection, make sense to the people who use them, and grow as you do. Here’s where I most often help.
Quality Management Systems
The backbone of a compliant, scalable operation. I build and strengthen the systems that keep product moving and regulators satisfied: deviations and CAPA, change control, out-of-specification and out-of-trend investigations, document control, and supplier quality. The result is a QMS that fits where you are today and scales with you — not a binder that sits on a shelf.
Outcome: fewer repeat findings, faster investigations, and a system that serves your team.
Inspection & Audit Readiness
Walk into an FDA or ISO inspection prepared. I assess where you stand, close gaps before they become findings, and get your team ready to tell a clear, confident story. Whether it’s a pre-approval inspection, a routine audit, or an ISO assessment, we’ll make sure the systems — and the people — are ready.
Outcome: fewer surprises, cleaner outcomes, and a team that stays calm under scrutiny.
Laboratory Quality & Data Integrity
Reliable data is the foundation of everything downstream. I help QC labs tighten operations, strengthen data integrity, and pursue or maintain ISO 17025 accreditation. From method validation and microbiology to the everyday discipline that keeps results defensible, I focus on labs whose data has to hold up to scrutiny.
Outcome: accurate, defensible results and a lab that’s audit-ready every day.
Quality Culture & Continuous Improvement
The best systems fail without a culture that owns them. Drawing on Lean and continuous-improvement principles, I help organizations build a genuine culture of quality — where teams take ownership rather than treat quality as someone else’s checkbox. Practical, right-sized improvements that stick.
Outcome: quality your organization owns, and gets better at over time.
How I work
Senior, hands-on, and sized to your stage. You work directly with me, I transfer the thinking as we go, and I aim to leave you stronger and more self-sufficient than I found you — whether that’s a focused project or ongoing support.
Not sure where to start? That’s a good first conversation.