Position Summary:
ultra innovative – Tackle rare and dynamic challenges
The Manager, Quality Assurance, will provide quality assurance oversight for the timelydisposition 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.
