Teams at Ultragenyx

Lead end-to-end management of deviations, investigations, and CAPAs for Technical Operations. Oversee manufacturing quality systems, drive Manufacturing Excellence and continuous improvement (Lean/Six Sigma), prepare for regulatory inspections, provide technical leadership on complex root cause analyses, standardize production systems, and build and lead a high-performing manufacturing/quality team.

Lead lot disposition and lot release activities for CMC QA, managing batch record review, COA verification, change control, and QMS/APQR trending. Coordinate cross-functionally with TechOps, Production Planning, QC, and regulatory stakeholders to ensure compliant, timely releases for Clinical, Early Access, and Commercial material. Drive continuous improvement, validate GxP applications and CSV deliverables, and perform Change Control QA duties as needed.

Manage QA oversight for timely disposition of gene therapy products across internal and external manufacturing sites. Independently review batch documentation, manage QP queries and certifications, lead new product and country launch disposition, execute quality transactions in Oracle, report disposition metrics, support audits/inspections, drive process harmonization, and contribute to SOP and quality system improvements.