Teams at Loyal

Lead design, administration, and continuous improvement of the electronic QMS and GxP CSV program. Manage SOP lifecycle, training, audits, inspection readiness, CAPA, and quality metrics. Partner cross-functionally to ensure FDA-CVM and other regulatory compliance for computerized systems and drug submissions, and build a scalable QA unit.

Operate as a hands-on COO for a clinical-stage veterinary biotech, owning finance, people, engineering, commercial launch ops, customer service, and company operating cadence. Scale the team from ~70 to ~150, deploy AI tooling, run S&OP and supply chain integrations, build regulated distribution and customer service for a 2027 product launch, and free the CEO to focus externally.

Lead FDA CVM regulatory strategy and clinical trial operations for veterinary longevity drugs. Own INADs and regulatory submissions, prepare FDA meeting materials, advise on study protocols, SAE reporting, labeling, and cross-functional regulatory risks. Manage and mentor 1-2 direct reports, maintain regulatory records, and serve as the internal FDA CVM subject matter expert throughout development and submission.