Associate Director Clinical Quality Assurance and GxP Compliance

Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team . Position Summary: ultra innovative – Tackle rare and dynamic challenges The CQA Associate Director provides strategic leadership and direction for the creation, development, and continuous evolution of quality assurance strategies, policies, programs, and initiatives. They are accountable for ensuring that organizational decisions, activities, and deliverables align with established quality standards and global health authority regulations. The Associate Director partners with senior leadership and cross-functional stakeholders to proactively evaluate and enhance quality systems, strengthen inspection readiness, and drive enterprise-wide process improvements. They champion and model a culture of compliance and quality excellence across the organization. They provide high-level oversight, guidance, and governance for the GCP Audit Program, ensuring effective planning, execution, resourcing, and risk mitigation. The Associate Director also identifies strategic opportunities to enhance operational efficiency, advance quality maturity, and support organizational growth. Work Model: Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite. Responsibilities: Serve as a senior subject matter expert (SME) on U.S. FDA, EMA, and ICH-GCP regulations, providing strategic oversight and guidance to Ultragenyx functional leaders. Direct the evaluation of non-compliances and risk areas across clinical programs and drive development of sustainable, cross-functional solutions. Provide leadership, mentorship, and strategic direction to QA personnel, SMEs, and contract service providers in the preparation, conduct, and reporting of GCP audits. Ensure capability building that aligns with organizational needs and evolving regulatory expectations. Oversee and govern the execution of all GCP audit types, including complex or high-risk audits (e.g., For-Cause, systemic failure evaluations). Ensure appropriate audit strategy, resourcing, and escalation pathways to support enterprise-level risk management. Serve as the senior SME representing Clinical Quality during regulatory inspections, providing leadership on issue presentation, regulatory interactions, and cross-functional coordination. Oversee the creation, review, and approval of storyboards and inspection narratives. Establish, direct, and oversee the enterprise Clinical Program Inspection Readiness strategy, including risk-based identification of key vendors and sites, mock inspections, war room preparation, and readiness governance. Ensure pro…