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Qonsult — About the Founder
01 / About / Founder · Shawn Kelley

I turn regulatory complexity into operational precision.

In regulated environments, compliance and quality are often treated as the same thing. Compliance gets written; quality gets lived.

When systems no longer hold in the daily work of the people running them, the gap eventually surfaces — during inspections, investigations, deviations, operational pressure, or critical moments where execution matters most.

That’s where my work starts.

02 / Track Record

Experience developed across regulated operations — from startup environments to established manufacturing.

Experience supporting quality and operational systems within plasma-derived therapeutics manufacturing — including equipment design, commissioning and qualification, operations, maintenance, and large-scale technology transfer in GMP biologics environments.

Quality system development within Health Canada–regulated startup environments — building operational structure across production, quality control, facilities, security, documentation, and inspection readiness under controlled-substances licensing.

Operational transformation within specialty chemicals manufacturing — supporting facility modernization, high-purity WFI implementation, CMMS, electronic signature systems, and multi-site operational harmonization.

Three operational environments. Three different scales. One common thread — recognizing vulnerabilities early, rebuilding systems that no longer held, and embedding operational integrity with the teams responsible for running them.
03 / Practice

Recognizing the signal early, identifying opportunities for improvement, and designing frameworks people can rely on.

Qonsult works through the operation itself — walking the process, speaking with the people who run it, identifying where pressure accumulates, and finding practical opportunities for improvement.

The objective is not more process. It is operational clarity, stronger controls, better execution, and frameworks that translate into systems people can rely on under real conditions.

Focus
Production Operations · Quality Management · Compliance · Process Improvement
Systems
eQMS · CMMS · Validation · Electronic Systems · Training Programs
Frameworks
GMP · GPP · GDP · 21 CFR Part 11 · ICH Q9
Languages
English · Français
04 / Field
Discipline

Fifteen years in the field — making high-stakes decisions in shifting conditions.

Team leadership. Advanced first response. Daily risk assessment. Cross-functional coordination in real operational environments.

Not a biographical footnote. The same discipline applies: recognizing the signal early, understanding where pressure accumulates, and making decisions that hold under real conditions.

Experience developed across production operations, quality management, compliance, investigations, operational leadership, and regulated environments where consistency, accountability, and resilience matter.

Focus
Operations · Quality Management · Compliance · Process Improvement
Systems
eQMS · CMMS · Validation · Electronic Systems · Training Programs
05 / Civic
Engagement

The principles don’t change by sector — only the language does.

Outside industrial mandates, I apply the same discipline to civic and community contexts — communications, governance, public-interest work, and support for the ethical practices of community organizations.

06 / Credentials

Education and professional standing.

Regulatory Authority
Quality Assurance Person (QAP)
Health Canada · controlled substances · security clearance 2021
Degree
B.Sc. Biology · Business Management Stream
Concordia University, Montreal 2016
Diploma
DEC, Pure and Applied Science
Dawson College, Montreal 2012
Publication
Metabolic Networks of the Human Gut Microbiota
Journal of Microbiology · Microbiology Society 2019
07 / Working with
Qonsult

Have a vision for where your operations need to be?

We advise, design the frameworks, walk through your operations with your teams, identify opportunities for improvement, and help implement systems people can rely on.

Qonsult supports organizations navigating operational growth, system pressure, quality transformation, compliance complexity, and implementation challenges within regulated environments.

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