Manager, QA Product Disposition in Bedford

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:

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.

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.