Jesica Gagne
I am a Food Safety, Quality, and Regulatory executive and the Founder of StoneGate Regulatory & Compliance, dedicated to helping regulated industries build practical, defensible compliance systems that protect consumers, strengthen brands, and improve operational performance.
My work centers on designing and implementing GMP, HACCP, SSOP, sanitation, environmental monitoring, FSMA, and GFSI programs (including SQF and BRCGS) that are execution-driven and sustainable in real manufacturing environments—not simply written for audits. I partner closely with operations, sanitation, maintenance, quality, and executive leadership teams to align food safety strategy with operational and financial objectives.
I have extensive experience working directly with regulatory authorities and audit bodies, including the FDA, USDA, Departments of Health, and military agencies, guiding organizations through inspections, enforcement response, and high-stakes compliance challenges. As a qualified Process Authority, I am authorized to conduct and formally sign off on process authority verifications for scheduled processes and aseptic systems within high-risk production environments.
I support startups, facility expansions, and operational turnarounds, delivering process optimization and cost-reduction strategies that improve throughput, reduce downtime, and strengthen manufacturing performance while maintaining rigorous regulatory standards. In addition to U.S. regulatory frameworks, I have supported international approvals and market entry across North America, Europe, the Middle East, and Asia-Pacific, including Canada, the United Kingdom, Israel, Australia, Japan, and South Korea.
I am known for being resourceful, disciplined, and highly execution-focused, with a commitment to building food safety systems that are trusted when it matters most.
• Six Sigma Black Belt
• Preventive Controls Qualified Individual (PCQI)
• Advanced HACCP
• Advanced SQF Practitioner
• SQF Advanced Internal Auditor
• BRC Certified
• ESHA Advanced Labeling Certification
• Humane Handling Certification
• Aseptic Processing Training
• Bachelors in Supply Chain & Logistics minor in International Business from Colorado Tech
• Six Sigma Black Belt
What do you attribute your success to?
I attribute my success to preparation, discipline, and the willingness to take responsibility when it matters most. In regulated industries, outcomes are rarely accidental — they are the result of consistent effort, attention to detail, and a commitment to doing the work thoroughly, even when no one is watching.
I have always approached my career with the mindset that credibility must be earned daily. That means understanding the regulations, understanding operations, and being willing to step into high-pressure situations with clarity and accountability.
I also believe strongly that every role within an organization matters. From sanitation teams to executive leadership, each person contributes to the integrity of a system. I have always valued and respected every level of an operation, because food safety is never the responsibility of one department — it is a collective effort. Recognizing that has allowed me to build trust across teams and strengthen performance from the ground up.
Resilience has also been a defining factor. Audits, inspections, and operational challenges test leadership. Each experience has strengthened my ability to stay steady, think strategically, and guide organizations forward with confidence.
Ultimately, I believe success is built on integrity, preparation, respect for people, and the discipline to execute consistently.
What’s the best career advice you’ve ever received?
The best advice I ever received was simple: “Know your material so well that no one can shake you.”
In regulated industries, confidence doesn’t come from position — it comes from preparation. That advice shaped how I approached every audit, inspection, and leadership role. When you truly understand your systems, your data, and your responsibilities, you don’t need to be the loudest person in the room — you can be the calmest.
It taught me that credibility is built long before high-pressure moments arise. Preparation creates clarity. Clarity builds confidence. And confidence becomes leadership.
What advice would you give to young women entering your industry?
Master the fundamentals. In food safety and regulatory work, credibility is earned through knowledge, preparation, and execution — not titles. Understand the regulations. Understand the science. Understand operations at the floor level. The strongest leaders in this field are those who can translate complex regulatory requirements into practical systems that work under real pressure.
Be disciplined. This industry will test you. There will be audits, inspections, enforcement moments, and situations where you must stand firm in your decisions. Build confidence through competence. When you truly understand your material and your systems, you don’t need to raise your voice — your clarity speaks for you.
Seek mentors who hold you accountable. Put yourself in rooms that stretch you. And never diminish your capability to make others comfortable. This field needs leaders who are steady, informed, and unafraid of responsibility.
Most importantly, remember that this work protects people. When you lead with integrity and purpose, your influence extends far beyond the facility walls.
What are the biggest challenges or opportunities in your field right now?
The greatest challenge in food safety and regulatory compliance today is managing accelerating complexity. Regulatory expectations continue to evolve across domestic and international markets, enforcement activity remains strong, and global supply chains introduce new variables in risk management, traceability, and oversight. At the same time, organizations are under pressure to increase efficiency, reduce costs, and scale quickly.
Environmental monitoring, sanitation controls, allergen management, and validation of preventive controls are no longer just audit checkpoints — they are core operational responsibilities. The margin for error is smaller, and public visibility is higher. In this environment, compliance cannot be reactive or document-driven alone. It must be embedded into daily execution.
However, this complexity also presents one of the most significant opportunities our industry has seen. Companies that build disciplined, execution-focused systems and foster a strong food safety culture gain more than regulatory compliance — they gain operational resilience, brand trust, and long-term sustainability.
The future belongs to organizations that treat compliance as strategy rather than obligation. When leadership aligns food safety with performance, accountability, and continuous improvement, it strengthens not only regulatory defensibility but overall operational maturity. In many cases, the very systems that protect consumers are the same systems that reduce waste, minimize downtime, and support global growth.
This is a pivotal moment in our industry. The opportunity is not simply to meet expectations, but to raise standards in a way that strengthens both people and performance.
What values are most important to you in your work and personal life?
Integrity is at the core of everything I do. In food safety and regulatory work, decisions impact real people — families, consumers, and entire organizations. I believe in doing what is right, even when it’s difficult, and standing firm when safety, compliance, and accountability are on the line.
I value discipline and execution. Ideas don’t protect consumers — systems do. I take pride in building programs that work in real operations, under real pressure, and withstand real scrutiny. Credibility is earned through consistency, clarity, and results.
Personally, I value resilience and responsibility. I’ve learned that strength is built through challenge, and growth comes from stepping into leadership with confidence and accountability. True influence isn’t about visibility — it’s about responsibility, execution, and leaving every system stronger than you found it.