CMC QA Senior Manager — Hybrid Lot Release & Compliance

Position Summary

The Senior Manager, CMC QA will report to the Sr Director, CMC Quality Assurance. This role supports the UGX QA Lot Disposition team, performing tasks related to disposition and documentation activities for UGX and UGT product lots. Responsibilities include oversight and management of the Lot Release system, ensuring lots are released according to schedule and patient need.

Flex:
This role typically requires onsite work 2–3 days per week, or more depending on business needs. Flex employees are scheduled to be onsite on certain days.

• Work proactively with Tech Ops planning function to ensure lot release dispositions are clearly and appropriately scheduled.
• Work proactively to schedule and facilitate Production Planning meetings to ensure complete planning for production and subsequent lot release.
• Review CMO executed manufacturing batch records per QA SOPs, according to schedule and internal KPI requirements.
• Ensure Certificate of Analysis documents are evaluated and found accurate by QC group.
• Understand QA systems such as raw material disposition, deviations, and change control to ensure batch records comply with these systems.
• Ensure batch record history files are compiled and KPIs are updated and current.
• Apply disposition to lots of material manufactured for Clinical, Early Access, and Commercial use, including Starting Materials, DS, DP, FG.
• Ensure archival of completed and reviewed manufacturing batch records.
• Drive change control accuracy, completeness, and transparency through the Change Review Forum.
• Perform the Change Control QA Role when needed.
• Identify opportunities for improvement in Lot Release and Change Control, using continuous improvement tools.
• Perform QMS data collection and trending for all APQR activities.
• Plan and coordinate cross‑functional meetings with QP, QO, RP.
• Other duties as assigned.
• For DS/DP, ability to be authorized to assign lot disposition (releases lots).

• Bachelor’s degree in a science or related technical field with no less than 7 years relevant industry experience.
• Working knowledge of desktop computers.
• Demonstrated detail‑oriented work capability.
• Strong compliance, organization, and communication skills.
• In‑depth knowledge of pharmaceutical regulations including 21 CFR Part 11, GMPs, GCPs, GAMP 5, and Annex 11.
• Extensive experience managing multiple validation projects, developing plans, managing project schedules, and directing vendor/contract resources to create CSV deliverables.
• Diverse experience validating GxP‑regulated applications for quality management, regulatory submissions, controlled document management solutions, and clinical development.
• Excellent communication, conflict resolution, influence, and problem‑solving skills.
• Deep understanding of validation methodologies applied to on‑prem applications and hosted environment.
• Strong attention to detail, quality oriented.
• Self‑motivated and comfortable in a fast‑paced, demanding, and dynamic work environment.

$174,900—$216,100 USD

• Generous vacation time and public holidays observed by the company
• Volunteer days
• Long‑term incentive and Employee Stock Purchase Plan or equivalent offerings
• Employee wellbeing benefits
• Fitness reimbursement
• Tuition sponsorship
• Professional development plans
• Benefits vary by region and country

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.