• Responsible for leading quality assurance practices for IEM’s digital quotation and estimation platform (OptIEMize) and related software tools. • Oversee QA execution, test automation, and release readiness while managing QA resources. • Partner closely with Product Owners, Scrum Masters, Software Developers, Engineering, and Sales. • Lead and manage QA activities within Agile/Scrum frameworks. • Promote shift-left testing practices and shared team ownership of quality. • Actively participate in Scrum ceremonies including backlog refinement and sprint planning. • Ensure test scope, automation readiness, and quality risks are considered during sprint commitments. • Oversee Cypress-based test automation, ensuring automated tests are maintainable, reliable, and aligned with business workflows. • Track and report Agile quality metrics such as defect trends, test coverage, and release stability.

• Provide strategic leadership and hands-on oversight for the GxP Quality Management System, ensuring compliance with FDA, EMA, and ICH guidelines relevant to clinical‑stage activities. • Own the eQMS and its core modules, including governance, optimization, user support, and coordination with IT, internal stakeholders, and vendors. • Lead document management processes, ensuring controlled documents (SOPs, policies, forms, work instructions) are current, accurate, and aligned with clinical and CMO/CRO operations. • Oversee the GxP training program, including role‐based curricula, onboarding, training effectiveness, and system performance within the eQMS. • Direct the deviation and nonconformance process, ensuring high quality investigations, root cause analysis, and effective corrective and preventive actions. • Own the CAPA system, ensuring quality issues are captured, assessed, prioritized, and addressed with clear plans and effectiveness checks. • Manage change control processes for GxP documents, quality systems, and relevant operational changes. • Establish, monitor, and communicate Quality System KPIs to senior leadership; identify trends and drive proactive improvements. • Support internal and external audits, regulatory inspections, and inspection readiness activities. • Collaborate with CMO, CDMO, and CRO partners to ensure alignment and oversight of Quality System expectations, documentation, and compliance. • Contribute to Quality strategy and governance as the company advances into later‑stage clinical studies and early commercial readiness.

• Complete monthly utilization management and appeals performance and process audits in alignment with applicable regulations, accreditation standards, and best practices. • Create and maintain progress reports and audit results in accordance with regulatory/accreditation requirements and internal processes. • Present audit results to leadership in a timely manner to address issues and ensure adherence to departmental procedures and regulatory/accreditation requirements (CMS, URAC, NCQA). • Continuously review and remain informed of all regulatory/accreditation requirements and updates impacting the coverage request and appeals processes. • Respond to inquiries from internal and external stakeholders regarding quality assurance processes, audit results, and compliance policies and procedures. • Work independently and with team members as warranted by audit assignment. • Assist in designing and implementing audit tools and programs, creating QA scorecards and guides in collaboration with all department stakeholders. • Provide ongoing performance feedback, to team leads to ensure consistent performance. • Assist management in identifying, evaluating, and mitigating operational, and compliance risks. • Work in collaboration with operational leaders to identify training opportunities and recommend improvements to Work Instructions, Job Aids, and Policy and Procedures to improve performance.

• Design, write, and maintain detailed test cases covering positive, negative, boundary, and edge-case scenarios • Execute functional, regression, and exploratory testing based on business and technical requirements • Develop and maintain automated regression test suites to improve testing efficiency and coverage • Perform API and integration testing across internal and third-party systems • Validate data integrity, including batch processing, data reconciliation, and migration testing • Conduct cross-browser compatibility testing (Chrome, Edge, Firefox) • Execute security testing validations, including authentication, authorization, and access controls • Collaborate with developers to troubleshoot issues and ensure high-quality releases • Support performance testing efforts, analyzing system behavior under load, stress, and latency conditions • Document defects, track issues, and ensure timely resolution • Communicate testing progress, risks, and results clearly with stakeholders