Founder and Principal

Liz Yasuda

Liz Yasuda is a Regulatory Strategist and Quality Systems expert with over fifteen years of experience in complex, high-stakes ingestible industries, ranging from life sciences and botanicals to industrial agricultural production and luxury enology. Operating as a consultant since 2017, Liz designs precision quality systems that transform mandatory compliance into a competitive advantage. She specializes in helping both asset-light virtual manufacturers and established facility operators navigate complex regulations, scale efficiently, and improve supply chain sustainability, saving client companies up to $4 million annually during the first 1-2 years of engagement.

Executive Impact:

  • Virtual Manufacturer & Supply Chain Optimization: Serving as Director of Quality Assurance & Regulatory Affairs for premier botanical and dietary supplement brands, Liz managed complex contract manufacturing organization (CMO) networks. Her strategic improvements to supply chain operations, ingredient sourcing, and CMO management generated over $4 million in annual cost savings to a company with a gross annual revenue of $17 million.

  • cGMP Compliance Infrastructure: Spearheaded initial FDA cGMP compliance audits and built regulatory infrastructures from the ground up. She authored foundational SOPs, implemented robust document control, and developed lot-specific Certificate of Analysis systems to protect brand owners.

  • Clinical Coordination: Managed complex clinical collaborations, including direct coordination with the FDA and Johns Hopkins University.

  • The Technical Advantage Liz’s analytical approach is rooted in hard science and industrial optimization. Before consulting in the life sciences, she led QA/QC initiatives for advanced industrial and technical manufacturers. There, she implemented rigorous ISO 9001 standards, managed CAPA systems, and executed supplier audits—training her to view FDA regulations through the lens of continuous process optimization.

Her career began at NASA as a Cassini Mission research assistant, analyzing Saturn's atmospheric data using FORTRAN and UNIX systems, and co-authoring a peer-reviewed Astrophysical Journal article. As a certified private pilot, Liz intrinsicaly understands that calculated risk requires zero-failure precision. Today, she applies that aerospace-level rigor to the manufacturing floor, ensuring consumer safety while maximizing your brand's market potential. Whether it’s a NASA satellite or a commercial kitchen's food safety system, the underlying principle is the same: systems-based risk mitigation and optimization.

FAQs

  • In aerospace engineering and aviation, calculated risk requires zero-failure precision. A system failure isn't just a loss of revenue; it's catastrophic. I apply that exact mathematical rigor and risk-mitigation strategy to the life sciences. Instead of viewing FDA and MoCRA regulations as a bureaucratic checklist, I view them as an engineering challenge. This allows me to build lean, highly efficient quality infrastructures that protect brand owners without the operational bloat typically found in traditional QA departments.

  • Traditional quality assurance is often treated as a defensive cost center. I treat it as an operational asset. For the specific client where we generated $4M+ in savings (on $17M in gross revenue), the ROI wasn't just about avoiding FDA fines. It came from deep-level supply chain optimization: restructuring their Contract Manufacturing Organization (CMO) network, qualifying better raw ingredient sources, eliminating manufacturing defects before they hit the market, and drastically improving floor-level operational efficiency.iption

  • An "asset-light virtual manufacturer" is a brand owner that outsources its physical production to a third-party Contract Manufacturing Organization (CMO). Many virtual manufacturers mistakenly believe that because they don't own the factory floor, they do not carry regulatory liability. Under FDA and new MoCRA guidelines, the brand owner is ultimately responsible for product safety and compliance. My expertise lies in building the rigorous CMO auditing systems and lot-specific document controls that protect virtual manufacturers from the liabilities hidden within their supply chain.

  • I operate as a high-level strategic partner. For established facility operators, I work alongside your existing Quality, Operations, and Marketing teams to identify bottlenecks, upgrade ISO 9001/cGMP systems, and implement CAPA frameworks. For startups and virtual manufacturers without an in-house QA department, I can architect your regulatory infrastructure from the ground up, providing the executive-level guidance needed until you are ready to scale an internal team.