Manager, QA Product Disposition
Bedford, NH - USA
Job Summary
ultrainnovative Tackle rare and dynamic challenges
The Manager QualityAssurancewill provide qualityassuranceoversight for thetimelydisposition of Ultragenyxs Gene Therapy products acrossall stages of manufacturing. This roleis responsible forindependently managing complex disposition activities ensuring compliance with global regulatory requirements and driving continuous improvement in quality systems.
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.
- 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 ensuretimelybatch 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 andexecute Quality Management transactions in Oracle to supporttimelyproduct release.
- Support and collaborate with the Sr. Director in monitoring and reporting disposition metrics;assistinidentifyingtrends and implementing initiatives to improve cycle time and right-first-time performance.
- Represent QA in cross-functional forums asneededand 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 ina timelyand effective manner.
- Contribute to the development and refinement of SOPs and quality system documentation.
- Bachelors degree in a scientific or technical disciplinerequired.
- 7years of experience in aGxP-regulated pharmaceutical or biotechnology environment.
- Strongexpertisewith 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 VeevaeQMSis 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 applicants 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
$131800 - $162900 USD
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 .
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.
Required Experience:
Manager
About Company
Ultragenyx is focused on developing first-ever approved treatments for rare and ultrarare diseases and moving the rare disease community forward.