Director External Quality Assurance

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 do.To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t 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 work.Ultimately, 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: ultra focused – Work together to fearlessly uncover new possibilities The Director, CMC QA will report to the Senior Director of CMC QA and be responsible for maintaining strategic responsibility over QA Manufacturing Operations, developing and implementing Ultragenyx CMC Quality approach for assigned programs, and working with colleagues to improve processes utilized to ensure product quality. In addition, this position will use strong management skills to independently manage external partnerships. In this role, in collaboration with key stakeholders in Technical Operations, DIR CMC QA provides quality oversight and support to ensure clinical through commercial development 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 needs. In 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 events,monitorthat recurrent events are properly escalated and resolved. Ensure root cause isdetermined, evaluateimpacton product quality, disposition, and corrective actions. Reviewandapprovechangesrelatedtofacility,computerizedsystems,laboratory,orproducts. 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 regulationsandguidance,ICHguidelines,Ultragenyxpolicies/procedures,andindustrybestpractices. Otherdutiesasassigned. Requirements: Bachelor’sdegreepreferablyinanEngineering,Biotechnology,Biological/Physicalsciences, orequivalent. 10+yearsofexperienceinaGMPbiopharmaceuticalmanufacturingenvironmentintechnical operations and/or quality. StrongworkingknowledgeandinterpretationofFDA,EMA,localregulationsandguidelines, Good Distribution Practices, ICHguidelinesand industry bestpractice. Experiencewithperformingtechnicalassessmentofchangesforpotentialimpactto qualification/validation of processes, equipment, utilities, facilities, and systems. CapabilityofcollaborativelyengagingwithContractOrganizations. Demonstratedhighpersonalandprofessionalethicalstandards. Possessesexcellentjudgmentwiththeabilitytothinkandactquickly.Mustbeabletoidentifycreative solutions to complex technical problems. Abilitytocommunicateclearlyandprofessionallybothinwritingandverbally. Strongorganizationalandprojectmanagementskillswithatrackrecordofmeetinggoals/objectives. Strongexperiencewithregulatoryauthorityinspections,includingbothFDAandEMA. 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 applicant's 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

$215,600 - $266,300 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 Long term incentive and Employee stock purchase plans or equivalent offerings Fitness reimbursement * 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 View email address on click.appcast.io . 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: View email address on click.appcast.io . Voluntary Self-Identification Survey We are dedicated to fostering an inclusive workplace environment that keeps our teams inspired, empowered, and free to share new ideas—and to better finding solutions that advance the treatment of those living with rare diseases. We invite you to voluntarily provide demographic information in a confidential survey at the end of this application to assist us in complying with legal requirements and managing our organization. Providing this information is completely optional and it will not be accessible or used by those involved inyourhiring or decision-making process. Your response – or decision not to respond, has no impact on your opportunity for employment. Responses to the voluntary self-identification requests will be confidential and securely maintained and only reported in the aggregate in support of the efforts outlined above. How would you describe you gender identity? * Select... How would you describe your racial/ethnic background? * Select... Select... Do you consider yourself to be part of the LGBTQ+ community? * Select... Do you have a disability or chronic condition (physical, visual, auditory, cognitive, mental, emotional, or other) that substantially limits one or more of your major life activities, including mobility, communication (seeing, hearing, speaking), and lear * Select... Which generation do you consider yourself to be part of? * Select... #J-18808-Ljbffr Ultragenyx Pharmaceutical Inc.