Senior Specialist, Quality Assurance Operations
Ultragenyx Pharmaceutical · Bedford, MA
Posted 16 days ago
or apply directly on Ultragenyx Pharmaceutical's site. We never take the application ourselves.
Is this posting real?
- This role has been open
- 16 days Ultragenyx Pharmaceutical's roles stay open a median of 41 days
- Reposted
- No
- Salary listed
- No 0% of Ultragenyx Pharmaceutical's roles list one
- Ghost-job risk at Ultragenyx Pharmaceutical
- high 5 stale, 6 reposted of 11 open
- Hiring momentum
- 54 roles opened in the last 90 days ↑ up vs. the prior 90 days
- Last confirmed on the employer's board
- 2026-09-17
Measured from postings appearing on and disappearing from Ultragenyx Pharmaceutical's own greenhouse board since 2026-08-03. Full hiring picture for Ultragenyx Pharmaceutical.
About this role
In this role as a Senior Specialist in Quality Assurance Operations, you will oversee QA activities at a gene therapy manufacturing facility, focusing on drug substance manufacturing. Your daily tasks will include reviewing production batch records, managing deviations, conducting QA walkthroughs, and collaborating with various departments to ensure compliance with GMP regulations. The position requires a commitment to quality and continuous improvement in a multi-product environment.
- benefits
- 4/5
- freshness
- 4/5
- career value
- 4/5
- role clarity
- 4/5
- pay transparency
- 0/5
Scored from the posting itself — how clearly the role is described, how much it says about pay and benefits, and how recently it was listed. Not a judgement of Ultragenyx Pharmaceutical as an employer.
What you need
- Minimum B.S. degree in scientific field such as microbiology, chemistry or biochemistry
- 5+ years of experience in biopharmaceutical, biotechnology, cell or gene therapy industries with Manufacturing and Quality roles
- Direct experience working at a biologic or advanced therapy medicinal product (ATMP) manufacturing site
- Knowledge and experience with drug substance and aseptic practices
- Knowledge of domestic and international GMP regulations and their application in the manufacture of biologics, cell, or gene therapy products
- Demonstrated ability to communicate technical information or complex situations to site management and/or health authority inspectors in a concise and clear manner
What you get
- Generous vacation time and public holidays observed by the company
- Volunteer days
- Long term incentive and Employee stock purchase plans or equivalent offerings
- Employee wellbeing benefits
- Fitness reimbursement
- Tuition sponsoring
Worth weighing
- Position requires on-site work in a controlled environment with specific gowning and safety protocols
- Physical demands include standing for extended periods, lifting up to 50lbs, and working in temperature-controlled environments
- Work schedule is Wednesday to Saturday with flexibility in start times, which may not suit everyone
Summarised from Ultragenyx Pharmaceutical's posting. Read the full original.
Listed by Ultragenyx Pharmaceutical on their greenhouse job board, last confirmed open on 2026-09-17. PitchMeAI is not the employer.
More roles at Ultragenyx Pharmaceutical
- Senior Director, US Medical Lead LC-FAOD and MPSsUnited States - Remote
- Associate Director, MarketingSao Paulo City, Brazil
- Executive Director, Global Pharmacovigilance Operations, Quality & ComplianceUnited States - Remote
- Associate Director, Regulatory Operations, EMEABasel, Switzerland