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Senior Manager, CMC QA

Ultragenyx Pharmaceutical

Job Location:

Brisbane, CA - USA

Monthly Salary: $ 174900 - 216100

Posted: 7 May 2026 (30+ days ago)

Application Deadline: 10 August 2026

Vacancies: 1 Vacancy

The job posting is outdated and position may be filled

Job Summary

Why Join Us

Be a hero for our rare disease patients

At Ultragenyx we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to achieve this goal our vision is to lead the future of rare disease medicine. For us this means going where other biopharma companies wont go challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science applying a novel rapid development approach making innovative medicines at fair and reasonable prices and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.

Our commitment and care for patients extends to our people so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth so employees can thrive in all areas of their lives in and outside of we want to be an organization where we would be proud for our family friends and children to work.

If you want to have a meaningful impact do the best work of your career and grow a lot both professionally andpersonally come join our team.

Position Summary:

ultrafocused Work together to fearlessly uncover new possibilities

TheSenior Manager CMC QA willbe responsible forthe Product Complaints Annual Product Quality Review and CMC Change Control Review Board programs and willmaintainstrategic responsibility over QA Manufacturing Operations and will implement and communicate Ultragenyxs CMC quality approach for the company. This role will direct and oversee operationsin accordance withGxPregulations and Ultragenyx standards.

Work Model:

Flex: This role will typically require onsite work 2-3 days each week or more depending on business many locations the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

Facilitate Global Annual Product Review/Product Quality Review in partnership with Quality Leads and collaboration with Tech Ops and Reg CMC
LeadUGXChange Control Review Board programand provide coaching to Change Ownerson the Change Control processas needed
Support the release of production lotsin accordance withUltragenyx procedures
Execution of Quality Systems in an Owner/SME or QA role for Deviations Change ControlsandProduct Quality Complaints
Lead and activelyparticipatein Continuous Improvement initiatives and projects ensuring a focus on increasing both efficiency and quality output from all processes used by the CMC QA and cross-functional partners
Design develop and review CMC QA standards and procedures (i.e. policy documents and SOPs). Review and support deployment of Quality Standards generated by the Quality System Department
Support theProduct Complaints functionin investigating reportedproduct qualityeventsas needed
Represent Ultragenyx to Health Authorities during inspections
Ensure activities and deliverablescomply withFDA EMA and local regulations and guidance ICH guidelines Ultragenyx policiesSOPsand industry best practices.
Communicate and promote a culture of quality and operational excellence
Other duties as assigned

Requirements:

ABachelorsdegree or equivalent work experience in QA Manufacturing Operations or related discipline.
8 years of experience in a GMP biopharmaceutical manufacturing environment in technical operations and/or quality.
Experience withmanagement of Change Control processand Review Board.
Experience with Product Disposition.
Demonstrate quality mindset and influences across the entire organization.
Strong understandingunique quality and manufacturing expectations from other regulatory authorities such as EMA ANVISA MHRA etc.
Expert knowledge of GMPs.
Flexibility and the ability to manage change.
Strong interpersonal skills and the ability to work well as part of a team.
Demonstrated ability for analytical and systematic thinking.
Experience with Product Complaint handling investigations and reportinga plus.
Fosters an environment of accountability diversity andspeaking up.
Demonstrated high personal and professional ethical standards.
Travel up to10% oftotalwork hours.

#LI-CT1 #LI-Hybrid

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

$174900 - $216100 USD

Full Time employees across the globe enjoy a range of benefits including but not limited to:

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

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. 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 .

See ourCCPA Employee and Applicant Privacy Notice.

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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.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us may be directed to:.

Required Experience:

Senior Manager

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