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Director, CMC QC Small Molecules

Ultragenyx Pharmaceutical
CompanyUltragenyx Pharmaceutical
CategoryManufacturing
LocationSouth San Francisco
RemoteOn-site (inferred)
EmploymentNot stated
LevelDirector
SalaryNot stated by the employer
Posted13 May 2026
Last verified10 Aug 2026
SourceEmployer ATS (greenhouse)
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Description
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: Outsourced QC Oversight   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 .   CMC QC Leadership – Small Molecules   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.   Analytical & Contract Laboratory Oversight   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.   External Partner & CMO/CL Management   Lead the  selection , qualification, and performan