Director, CMC QC Small Molecules

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 dedicated – Your biggest challenges yield rare possibilities The Director, CMC Quality Control – Small Molecules is responsible for providing technical and strategic oversight of all outsourced QC activities supporting Ultragenyx small molecule drug substance and drug product programs across development and commercialization. This position reports to the Executive Director, CMC ‑ QC. The role leads QC governance for contract manufacturing organizations (CMOs), contract laboratories (CLs), and other external partners, ensuring compliant, phase ‑ appropriate , and inspection ‑ ready execution. QC testing e xperience supporting rare and ultra ‑ rare disease development models —characterized by lean organizations, accelerated timelines, and high reliance on outsourced partners—is a strong asset. Experience with biologics QC is considered an additional advantage, particularly for candidates supporting hybrid portfolios in a virtual QC model. 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: Provide end ‑ to ‑ end QC oversight for a 100% outsourced operating model , supporting small molecule drug substance and drug product programs across clinical and commercial stages . Provide technical and strategic leadership for small molecule QC , including solid oral dosage forms and sterile parenterals , with hands ‑ on oversight of analytical testing, method validation, investigations (deviations, OOS), CAPAs, and lifecycle management in compliance with ICH/USP/Ph. Eur. /JP requirements. Perform technical review and approval of outsourced analytical data, method validation, stability programs, reference standards, specifications, and shelf ‑ life assignments , ensuring phase ‑ appropriate QC strategies and data integrity. Lead the selection , qualification, and performance management of CMOs and contract laboratories , serving as the QC technical representative during manufacturing campaigns and managing quality agreements, scopes of work, and issue resolution. Collaborate cross ‑ functionally and lead CMC QC contributions to regulatory submissions , inspections, and audits, including authoring and defending QC sections and managing responses to health authority observations. Oligonucleotide Biologics QC (Advantage) - Provide QC oversight or strategic input for biologics and/or oligonucleotide programs , including analytical methods, stability, and regulatory interactions, as needed. Lead selection, qualification, onboarding, and…