Senior Manager, Quality Assurance, Japan

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 focused – Work together to fearlessly uncover new possibilities The Senior Manager, Quality Assurance Japan, supports the Head of Quality Assurance Japan and leads day to day QA operations to sustain product launch and commercial activities. Partnering with CMC Quality, QC, Technical Operations, and Supply Chain, the role ensures operations aligned with Japanese GMP and GQP—while considering re lated GDP guidelines , GCP , and PV requirements —and supports the establishment of the local QA support model and supply chain model, providing technical assistance as needed. Work Model: Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed. Responsibilities: Under the direction of the Head of Quality Assurance Japan, lead day ‑ to ‑ day execution of QA activities and contribute to on ‑ time completion. Support compliance with internal policies, SOPs, industry standards (GMP/GQP/GDP), and PMDA/MHLW notifications and guidance; support inspection readiness, day ‑ of activities, and drafting post ‑ inspection responses. Perform batch disposition (product release) in accordance with Japanese GQP requirements and support communications with regulators on quality matters. Oversee domestic product testing and visual inspection results, and promptly report any manufacturing, quality control, or product quality issues identified during batch disposition activities to the General Marketing Compliance Officer, the Head of Quality Assurance Japan, and relevant stakeholders. Author, revise, and implement SOPs and quality documents; support operation and continuous improvement of the QMS in line with corporate standards. Collaborate with CMC QA, QC, Technical Operations, Regulatory Affairs, and Supply Chain to ensure a safe, uninterrupted, and effective supply of products that meets patient and regulatory expectations. Execute and drive quality processes such as change management, deviations/CAPA, product quality complaint investigations, and product recall activities in collaboration with Global Quality. Draft and manage Quality Technical Agreements and, ensure their effective implementation, including support for GxP audits and supplier quality oversight of contracted partners such as CMOs, contract testing laboratories, and distributors. Provide QA support for artwork management and facilitate Japanese–English communications between domestic partners and global technical team. Participate in external collaborations to stay current with domestic policies, practices, and regulatory guidance, and work ... (truncated, view full listing at source)