• Maintains quality oversight for multiple projects, vendors, and/or systems, ensuring consistent and compliant execution. • Acts as escalation point for complex, high-risk or systemic quality issues, inspection risks, and compliance concerns within assigned scope. • Leads complex investigations, including suspected serious breaches, fraud and misconduct and systemic quality issues; ensures robust CAPA development, effectiveness checks, and trend analysis. • Acts as lead auditor for routine audits and leads complex audits and inspections; defines inspection response strategy, coordinates execution, and supports senior management during high‑risk or regulatory‑critical inspections. • Leads inspection readiness activities. • Acts as subject matter expert for one or more QMS elements (e.g. CAPA, Audit Program, Vendor Quality Management, Inspection Readiness, Training Compliance, CSV Quality Oversight) and supports continuous improvement initiatives within those areas. • Develops, reviews, and maintains controlled documents within assigned scope and ensures alignment of assigned processes, procedures, and tools with the company QMS and applicable GxP regulations. • Leads and/or performs quality risk assessments and participates in risk management reviews. • Reports KQIs, KPIs, quality metrics, trends, and improvement opportunities. • Performs audits, acts as lead auditor for complex audits and supports audit program planning and execution. • Mentors auditors and supports audit quality and consistency. • Leads vendor qualification and oversight activities, including risk assessments, RFIs, performance monitoring, and re‑qualification activities.

• Oversee day-to-day operations at multiple clinical research sites within the region. • Ensure trials are conducted in full compliance with Good Clinical Practice (GCP), FDA, ICH, and protocol requirements. • Lead all phases of clinical trial execution including site initiation, monitoring, subject recruitment, and study close-out. • Ensure consistent, high-quality data collection and timely patient enrollment across all sites. • Lead, mentor, and support site-level teams, including Principal Investigators, Clinical Research Coordinators, and other staff. • Promote a collaborative and high-performance work culture through coaching, development, and team-building. • Proactively resolve site-level challenges and performance issues. • Ensure strict adherence to study protocols, IRB/ethics board guidelines, and applicable federal regulations. • Conduct internal site audits and oversee corrective actions when necessary. • Maintain accurate and timely documentation, including ICFs, AEs, SAEs, and source documents. • Manage site budgets and ensure adherence to financial agreements. • Support contract negotiations and oversee invoicing and payment processes. • Collaborate with sponsors, CROs, and internal departments to ensure seamless clinical trial execution. • Monitor site performance metrics (e.g., enrollment, retention, data quality) and provide regular reports to leadership.

• Lead regional technology vendor performance and partner with franchise owners and regional leadership. • Manage day-to-day relationships with local and regional technology vendors. • Track vendor performance against contracts and SLAs. • Partner with Regional General Managers and FOs to proactively identify opportunities to increase sales. • Drive the resolution of key regional issues: technical issues, process & knowledge gaps, new feature & development needs.

• Own end-to-end implementation, account management, and customer success for partner accounts — responsible for driving measurable outcomes within named partnerships • Lead internal implementation efforts, working cross-functionally with stakeholders across Product, Member Marketing, and Clinical Operations • Drive marketing and awareness of Oshi Health within named accounts, ensuring prospective members are well-educated on available GI solutions within their benefit structure • Pull and analyze key performance data within internal Oshi Health systems to highlight success stories and communicate performance to clients • Deliver quarterly business reviews (QBRs) to customers, reinforcing value and driving continued account growth • Influence key stakeholders through clear, confident external communication and cross-functional alignment