Who We Are
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We believe in work done with integrity — solutions built by people who are trusted to build them. At Kopse Group we don’t manage from a distance or prescribe from a deck. We engage, we discover, and we build what our clients actually need. Our goal is simple: that when the work is done, our clients can step back, watch proudly, and sleep soundly.
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Most consulting firms get the requirement and fill the seat. We don’t work that way.
We don’t build solutions on uncharacterized problems. Before anything is proposed, we diagnose. Before anything is implemented, the client understands the tradeoffs. And when the work is done, we don’t leave — we stay through stabilization until the solution holds on its own.
For change management we use The Nucleus Method™ — change built from the core out, with roadblocks escalated directly to the decision maker. By the time the organization feels the change, the center has already held.
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Honest counsel over comfortable answers.
We tell clients what they need to hear, not what they want to hear.
Our people are our standard.
Every consultant we place has been vetted, assessed, and matched before they ever meet a client. We provide our recommendation — and we stand behind it completely.
Respect is the baseline.
For the craft, for the client, for the consultant doing the work. It’s not a courtesy — it’s how we operate.
Accountability without abandonment.
When something is harder than expected we have the conversation, we scope the work correctly, and we see it through.
Precision solutions that outlast us.
We build for handoff, not dependency. When the engagement ends the work continues — because we built it that way from the start.
Hi, I’m Joseph T Swigunski
I’ve spent nearly two decades developing quality systems, ensuring compliance to critical quality programs, delivering successful inspection outcomes, and enterprising quality risk management across biotechnology, cell and gene therapy, pharmaceuticals, and medical devices at a global level.
I have authored industry publications, contributed to official ICH Q9(R1) training materials on behalf of EFPIA, and spoken at major industry conferences and international engineering forums as an expert on quality, risk, and compliance topics.
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Author — Risk Assessment Section
PDA Technical Report No. 39 (Revised 2021)
Authored the risk assessment section of PDA Technical Report No. 39, Guidance for Temperature-Controlled Medicinal Products — contributing the risk assessment framework to one of the industry's primary technical references on cold chain quality management.
Contributor — ICH Q9(R1) Training Materials, EFPIA
Contributed to the development of official ICH Q9(R1) training materials on behalf of EFPIA, focused on bias and subjectivity in quality risk management — one of the six core revision topics in the 2023 finalization of the updated guideline. These materials are used globally across the pharmaceutical and biotechnology industry.
Invited International Speaker — 2024IEC, Taizhou, China
2024 International Engineering Congress · November 2024
Presented on ICH Q9(R1) and its practical implications for emerging quality organizations at a WFEO, FEIAP, and UNESCO-affiliated international congress attended by leaders from more than 40 countries and regions.
EFPIA Working Group Representative — ICH Q9(R1)
Represented the European Federation of Pharmaceutical Industries and Associations in the ICH Q9(R1) Expert Working Group, contributing to the revision of the pharmaceutical industry's foundational quality risk management guideline.
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Regulatory Response — Class II Implantable Medical Device
Delivered a fit-for-purpose response to a health authority clarification during Class II implantable device recertification — draft to approved executive report in five days, with escalation to the Head of Operations and Regulatory. Certification timeline preserved without disruption.
Veeva eQRM Implementation — Commercial Cell & Gene Therapy
Delivered a fit-for-purpose Veeva eQRM implementation for a commercial cell and gene therapy company — on time, with full data migration and field mapping, and the judgment to recommend partial deployment when the full tool didn't serve the business.
Data Integrity Defense — Electronic Signature Compliance
Blocked an IT migration decision that would have reduced quality approvals to username-only authentication — no password, no 2FA — in direct conflict with 21 CFR Part 11 and Annex 11. The gap was being rationalized through a risk assessment. Identified the compliance failure, pushed back against the proposed justification, and ensured a fully compliant solution was implemented.
Global Biopharmaceutical Manufacturer
Led enterprise quality risk management improvement initiatives supporting commercial manufacturing to ensure regulatory compliance across a complex global organization of more than 30+ sites and functions, with no critical or major findings.
Cell & Gene Therapy Organization
Supported quality system development and operational readiness during a period of rapid growth, helping the organization build scalable systems capable of supporting clinical and commercial ambitions, across all critical to quality operational functions. Helping cold chain packaging reach a six sigma incident rate.
Global Supply Chain Program
Developed risk-based approaches to supplier oversight and quality governance across international supply networks, strengthening both compliance posture and operational resilience.
Kopse Group carries my family name tracing back to my great-grandmother, Hazel Kopse (née Moran), and the environment she created for everyone around her. She had an 8-track player, a tube TV with a big rotary dial you had to get up to change, a kettle that was always piping hot, and black cherry ice cream in the freezer for whenever we visited. My father came from humble beginnings. She gave him free room and board while he went to college — and he became the first in our family to graduate, an electrical engineer out of Saint Louis University.
She expected nothing in return. She created an environment for education and excellence.
That is what Kopse Group is built on — a firm that serves its clients completely, and measures its success by theirs.