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Director External Quality Assurance

Ultragenyx

Job Location:

Novato, CA - USA

Monthly Salary: $ 215600 - 266300

Posted: 11 June 2026 (30+ days ago)

Application Deadline: 19 November 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The job posting is outdated and position may be filled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

The Director CMC QA will report to the Senior Director of CMC QA andbe responsible formaintainingstrategicresponsibilityoverQAManufacturingOperationsdevelopingandimplementingUltragenyxCMC Quality approach for assigned programs and working with colleagues to improve processesutilizedto ensure product addition this position will use strong management skills to independently manage external partnerships.

Inthisroleincollaboration withkeystakeholdersin TechnicalOperationsDIRCMCQAprovidesquality oversight and support to ensureclinical through commercialdevelopment lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines.

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:

Review/approve investigation of operations in manufacturing/laboratory or other related operationsandleadthestrategicdiscussionforinvestigationswithrespecttooperationsrelated matters. Oversee resolution of quality eventsmonitorthat recurrent events are properly escalated and resolved. Ensure root cause isdetermined evaluateimpacton product quality disposition and corrective actions.
Reviewandapprovechangesrelatedtofacilitycomputerizedsystemslaboratoryorproducts.
Perform finalreviewoftestdata/reportstoensureconformancetotheestablishedspecifications and standard operating procedures.
Driveexecutionofriskassessmentsrelatedtomanufacturingprocessesforsmallmolecule biological products and novel therapeutics (i.e. mRNA).
Managethelifecycleofproductswithintheportfolioaccordingtoqualitystandards.
ProactivelyengagewithTechOpsinaddressingqualificationrequests.
ProactivelyengagewithTechDevelopmentinaddressingprocessdevelopmentrequests.
Develop andmaintainprocedures and practices in compliance with FDA EMA and local regulationsandguidanceICHguidelinesUltragenyxpolicies/proceduresandindustrybestpractices.
Otherdutiesasassigned.

Requirements:

BachelorsdegreepreferablyinanEngineeringBiotechnologyBiological/Physicalsciences orequivalent.
10yearsofexperienceinaGMPbiopharmaceuticalmanufacturingenvironmentintechnical operations and/or quality.
StrongworkingknowledgeandinterpretationofFDAEMAlocalregulationsandguidelines Good Distribution Practices ICHguidelinesand industry bestpractice.
Experienceusingandfacilitatinguseofriskmanagementtools(FMEAPHAetc.)
Experiencewithperformingtechnicalassessmentofchangesforpotentialimpactto qualification/validation of processes equipment utilities facilities and systems.
CapabilityofcollaborativelyengagingwithContractOrganizations.
Experiencedinallphasesofbiologicandsmallmoleculedrugdevelopment.
Demonstratedhighpersonalandprofessionalethicalstandards.
solutions to complex technical problems.
AbilitytointerpretandrelateQualitystandardsforimplementationandreview.
Abilitytocommunicateclearlyandprofessionallybothinwritingandverbally.
Strongorganizationalandprojectmanagementskillswithatrackrecordofmeetinggoals/objectives.
StrongexperiencewithregulatoryauthorityinspectionsincludingbothFDAandEMA.
Travelwillberequiredwhenappropriate(approximately10%)

#LI-CS1#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

$215600 - $266300 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:

Director

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