Background & Expertise
A decade on the floor.
Ten years at TJP Labs built a foundation that no classroom can replicate — navigating real audits, solving real production problems, and delivering results that show up in the numbers.
TJP Labs — ten years in the making.
I spent a decade at TJP Labs as a pharmaceutical production professional, working across every layer of a regulated manufacturing operation. That experience — from equipment installation to multi-agency audit management — is the foundation of every engagement I take on.
My work at TJP Labs spanned production management, operational excellence, and regulatory compliance. I led teams through Health Canada GMP inspections, FDA audits, and NSF/ISO assessments — not as a support function, but as the person responsible for the outcome.
On the operational side, I drove OPEX targets across production lines, improving equipment efficiency and reducing waste through disciplined process analysis. I oversaw the installation and commissioning of major equipment including GD and Hancheng systems, managing the full lifecycle from vendor coordination through qualification and routine operation.
That combination — deep regulatory experience across Health Canada and the FDA, alongside hands-on production accountability — is what I bring to every client engagement. I understand what auditors look for because I've stood in front of them. I understand what slows production down because I've fixed it.
Areas of depth
Technical expertise.
Regulatory Audit Management
Direct experience managing Health Canada GMP inspections, FDA audits, and NSF/ISO assessments — preparation, execution, and response.
Operational Excellence
Structured approach to hitting OPEX targets: production rate improvement, waste reduction, equipment utilization, and measurable efficiency gains.
Equipment Installation & Qualification
Full-lifecycle management of pharmaceutical equipment programs — from vendor selection and installation through IQ/OQ/PQ and routine operation.
GMP Compliance Systems
Building and maintaining the documentation, procedural, and quality frameworks that satisfy both Health Canada and FDA expectations and hold up under inspection.
Production Process Design
Designing and simplifying manufacturing workflows to reduce complexity, minimize deviation risk, and support consistent, repeatable output.
Regulatory Submissions
Preparation and management of Health Canada DEL, NDS, and ANDS filings, as well as FDA ANDA and CMC documentation for both markets.
Working with me
How I work.
Every engagement follows the same principles — regardless of scope or complexity.
Floor-first diagnosis
I start on the production floor, not in the boardroom. Understanding how your operation actually runs — not how it's documented to run — is the only way to identify what's really holding you back.
Practical recommendations
Every recommendation I make is implementable by your team with your existing resources. I don't design solutions that require a consultant to maintain.
Direct accountability
You work with me directly — not a project manager relaying messages to a junior analyst. I'm accountable for the outcome of every engagement.
Knowledge transfer
My goal is to leave your team more capable than I found them. Every engagement includes deliberate knowledge transfer so the improvements stick after I'm gone.