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.
- 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.
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 [email protected].
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.
Skills Required
- Bachelor's degree in a scientific or technical discipline
- 7+ years experience in a GxP-regulated pharmaceutical or biotechnology environment
- 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
- Strong organizational, communication, and problem-solving skills
- Ability to lead through influence and manage complex projects independently
- Experience with Veeva eQMS
- Majority of work conducted on-site (Core Lab & Ops)
Ultragenyx Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Ultragenyx and has not been reviewed or approved by Ultragenyx.
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Healthcare Strength — Benefits begin on the first day with multiple medical plan options alongside dental and vision coverage. Employer-funded HSA contributions and employer-paid mental health support via Spring Health add notable depth to healthcare support.
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Leave & Time Off Breadth — Paid time off is broadened by two fully paid company shutdown weeks in August and December in addition to holidays and baseline vacation. Paid sick time, paid volunteer time, and a substantial paid leave program further expand time-off support.
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Retirement Support — Retirement support includes a 401(k) program with a match on employee contributions and immediate vesting. An employee stock purchase plan discount also strengthens the overall financial rewards package.
Ultragenyx Insights
What We Do
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.
