Job Description

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 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 and personally, come join our team. During the COVID-19 pandemic, we are committed to the health and safety of our employees and prospective employees, which means at this time our interview processes may include virtual discussions, interviews, and onboarding. Please note that compliance with local regulations and safety protocols is a condition of employment at Ultragenyx. Elements of safety protocols may include, but are not limited to: work from home requirements, regular or symptom-based covid testing, providing valid evidence of vaccination, mask wearing, and physical distancing. US based roles: Full vaccination against COVID-19 is a condition of employment at Ultragenyx. This requirement applies to almost all roles at Ultragenyx based in the U.S., with very limited exceptions. If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation. Roles based outside the US: If the role requires travel to the US or another country that requires evidence of covid vaccination for entry, candidates and employees will be required follow the local regulations and corporate policy regarding vaccination evidence submission. Position Summary ultradedicated - Your biggest challenges yield rare possibilities We are seeking a collaborative and innovative individual to manage the Quality oversight of Computer Systems Validation (CSV) at Ultragenyx. In this role, you will manage the operations of the QA CSV group and serve as Quality lead on GMP, GCP and GVP computer systems projects. This will include partnering with IT Project Management to develop project timelines and deliverables, as well as representing Quality on the IT Change Review Board. You will provide strategic direction on Computer Software Assurance processes and lead continuous improvement activities aimed at increasing their effectiveness and compliance. This is a position in the Quality Systems group. In this role you will collaborate closely with other functions within Ultragenyx, including Technical Operations, Clinical Operations, Drug Safety, Regulatory and Legal Compliance. Ultragenyx has multiple Gene Therapy programs in development in the rare and ultrarare disease space, and a robust pipeline. We are building a state of the art GMP manufacturing facility in Bedford, MA. Join our team! Work Model Flex: This is a Flex role, this role will typically require onsite work 2-3 days each week, or more depending on business needs.

Responsibilities Manage the framework, resourcing, actions and timelines of the QA CSV role in IT projects Act as QA CSV lead on computer system validation projects, ensuring that project deliverables for GxP systems meet the requirements of US and international regulatory agencies Perform periodic reviews of computer systems regulations and guidance documents and provide IT and the Quality Systems group with an analysis of current industry and Agency trends for Computer Software Assurance Develop and manage the process for assessing and communicating whether vendor contracts and audit results adequately mitigate risks identified during Computer Software Assurance activities Partner with IT on the continuous improvement and compliance of the CSV Program, including the development and revision of computer systems SOPs and validation templates, using a compliant, efficient and risk-based approach Serve as Quality lead on the IT Change Review Board and partner with IT Project Management during project scoping and design Support GxP vendor audits and Agency inspections

Requirements 8 plus years experience in the pharmaceutical, biotech or other related life-sciences industry; experience with computer system validation is a requirement Experience validating the following software systems categories using GAMP5 methodology: enterprise quality systems (EDMS, QMS, LMS), clinical systems (ePro, IRT, EDC), ERP, lab systems, manufacturing systems Expertise in the following regulations and guidelines: 21 CFR Part 11, Annex 11, ICH E6R2, GAMP5 Proficient in utilizing risk management tools Ability to write concisely and provide clear feedback on procedures and validation documents Exceptional teamwork and collaboration skills with internal and external parties Acts with a sense of urgency--self-motivated, with the ability to demonstrate initiative

Full-time #LI-CZ1 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 & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: or by emailing us at . For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information. See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy. 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: .