Kevin Soiseth

About Kevin Soiseth

SEASONED QA/QC & COMPLIANCE LEADER & ISO SYSTEM ARCHITECT → Strategic risk expert…

Experience

1. Vice President, Quality, Regulatory Affairs, R & d & Legal Supplement Manufacturing & Packaging

   Swanson Health

   Jan 2017 — Present · Fargo, ND, US

   As a senior executive at a $350M PE-owned direct-to-consumer dietary supplement company with 26K+ products, I reported to the CEO and led 6 direct and 54 indirect reports with a $6.8M budget. I stabilized manufacturing and packaging for ~160 branded formulas and 1K outsourced products in a 220K sq. ft. facility producing 1.6B units annually—resolving disruptions, enhancing quality, and optimizing operations. Swanson Health holds NSF, UL GMP, MCIA Organic, AHF Halal certifications, and maintains full U.S. FDA compliance.EXECUTIVE HIGHLIGHTSSTRATEGIC LEADERSHIP• Delivered 40% YoY international growth across 300 markets, expanding into Asia Pacific, Europe, MENA, and Latin America while sustaining $350M revenue. Embedded quality as a business discipline, streamlining supply chain and audit systems.• Generated $6.5M in new annual sales by advocating continued NMN, NAD, and CBD production despite regulatory uncertainty; testified in North Dakota CBD policy hearings.• Preserved ecommerce compliance on Amazon, Walmart, and Target; negotiated directly with Amazon to influence supplement testing and policy, minimizing disruptions and expanding listings.QUALITY ASSURANCE & CONTROL• Achieved top-tier NSF, UL, and AHF audit ratings (2020-22). Zero FDA audit findings.• Applied Lean Six Sigma and Pareto analysis to reduce defects and consumer complaints, improving efficiency and throughput.• Managed recalls, adulteration incidents, and pest events without disruption while leading FSMA and Food Safety programs.COMPLIANCE & R&D• Advised on compliance & legal matters, defending against Prop-65, TM violations, and class actions with a 98% success rate. Strengthened regulatory claims using AI tools and peer-reviewed science.• Accelerated Halal certification from 18 months to 3 and advanced staff development—promoting two to Director roles.• Established an R&D pilot lab reducing product development cycle time by 88% enabling rapid, compliant cGMP innovation.

Education

• North Dakota State University

  Bachelor of Science - BS

• Harvard Kennedy School

  Certificate

• North Dakota State University

  Master of Business Administration - MBA

• North Dakota State University

  Master of Science - MS

Skills

• Quality Management
• Negotiation
• Clinical Monitoring
• Six Sigma
• Gxp
• Auditing
• Drug Development
• Gcp
• Biopharmaceuticals
• Clinical Trials
• Clinical Research
• CRO
• Capa
• Clinical Data Management
• Cgmp
• Clinical Operations
• 21 Cfr Part 11
• Problem Solving
• Glp
• Change Management
• Lims
• Budgeting
• Regulatory Affairs
• Clinical
• Lss
• Quality System
• Quality Systems
• Ich-Gcp
• Biotechnology
• Mentoring
• Pharmaceuticals
• Strategic Planning
• Continuous Improvement
• Compliance
• Pharmaceutical Industry
• Sop
• Clinical Development
• Fda
• Validation
• Gmp