Quality and Governance
Clinical quality, inspection readiness, regulatory/device guidance, HIPAA-compliant workflows, and vendor governance across clinical and patient-facing programs.
Clinical Quality and Inspection Readiness
Context
Global clinical technology and operations environments with formal QA and inspection expectations.
Evidence
GCP, ICH E6(R2/R3), QA oversight, and zero-findings pre–Phase III audit experience.
Role
Managed quality and governance activities across platform, program, and operational environments at Ultragenyx.
Regulatory and Device Guidance
Context
Device and digital program support involving protocol design and program-level regulatory awareness.
Evidence
FDA- and EMA-aware program work, Dexcom CGM mobile app development context, protocol guidance to SMT and program leaders.
Role
Provided device and digital program guidance in protocol and planning contexts, including support to SMT and program heads.
HIPAA and Site Workflow Governance
Context
Patient-facing workflows in contracted-provider settings, telemedicine, payer access, and clinic coordination.
Evidence
HIPAA-compliant workflows where required; contracted-provider contexts; in some cases as a BAA; BCBSTX, Texas Medicaid, and Diabetes Housecall operations.
Role
Built and governed SOPs, claims workflows, scheduling, telemedicine coordination, medical-necessity processes, and clinic-facing access operations.
Procurement and Vendor Management
Context
CRO, eCOA, platform, and device vendors supporting regulated clinical programs and patient-facing systems.
Evidence
Procurement and logistics leadership; IQVIA vendor performance management; CAPA resolution involving IQVIA and Thread Research; gene therapy programs in GSD1a and GSDIII.
Role
Led procurement and vendor management for CROs, eCOA vendors, and device logistics; participated in vendor performance management and CAPA resolution.