Manager, QA Product Disposition

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: ultrainnovative – Tackle rare and dynamic challenges The Manager, Quality Assurance, will provide quality assurance oversight for the timely disposition of Ultragenyx’s Gene Therapy products across all stages of manufacturing. This role is responsible for independently managing complex disposition activities, ensuring compliance with global regulatory requirements, and driving continuous improvement in quality systems. Work Model: Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site. Responsibilities: Manage and independently review batch documentation for investigational and commercial products. Lead and support disposition-related quality activities across internal and external manufacturing sites, ensuring continuity through effective backup coverage, and driving cross-functional alignment to meet compliance and operational goals. Manage queries from internal and external Qualified Persons (QPs), to ensure timely batch certification, QP declarations, and maintenance of the Product Specification File (PSF). Lead disposition activities for new product introductions and new country launches in collaboration with CMC, Regulatory, and Supply Chain teams. Manage and execute Quality Management transactions in Oracle to support timely product release. Support and collaborate with the Sr. Director in monitoring and reporting disposition metrics; assist in identifying trends and implementing initiatives to improve cycle time and right-first-time performance. Represent QA in cross-functional forums, as needed and contribute to global disposition strategy and process harmonization. Support regulatory inspections and internal audits as a subject matter expert for product disposition. Escalate quality risks and issues in a timely and effective manner. Contribute to the development and refinement of SOPs and quality system documentation. Requirements: Bachelor’s degree in a scientific or technical discipline required. 7+ years of experience in a GxP-regulated pharmaceutical or biotechnology environment. Strong expertise with product disposition, batch record review, or QA operations. Familiarity with cGMP regulations and quality systems (US/EU). Experience with Oracle or similar ERP systems is highly desirable. Strong organizational, communication, and problem-solving skills. Ability to lead through influence and manage complex projects independently. Experience with Veeva eQMS is a plus. #LI-KJ1 #LI-Onsite The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location. This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment. Pay Range $131,800—$162,900 USD Full Time employees across the globe enjoy a range of benefits, including, but not limited to: · Generous vacation time and public holidays observed by the company · Volunteer days · Long term incentive and Employee stock purchase plans or equivalent offerings · Employee wellbeing benefits · Fitness reimbursement · Tuition sponsoring · Professional development plans * Benefits vary by region and country Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com. See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.