- Location
- Bedford, MA
- Workplace
- Onsite
- Department
- Ultragenyx Gene Therapy - Quality Assurance Operations
- Seniority
- Manager
- Experience
- 7+ years
- Source
- Greenhouse
Description
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.
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.
