Job Title

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 lifechanging treatments. We do this by following 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. We want to be an organization that we would be proud for our family, friends, and children to work for. If you want to have a meaningful impact, do the best work of your career, and grow professionally and personally, come join our team. Position Summary Ultragenyx is looking for a Director, Global Compliance Audit to execute the external audit program, internal selfinspection program, and support the audit lifecycle for vendors and suppliers. The candidate will communicate assessments of compliance and inspection risks to support businesscritical decisions that may impact Quality and Regulatory timelines and decisions. The ideal candidate has experience as a Quality or Operations (Manufacturing and / or QC) professional with GxP Compliance Auditing of pharmaceutical manufacture / testing / distribution, identifying and developing procedures and process improvements, analyzing Corrective Action / Preventative Action plans, is selfmanaged, and able to travel up to 50% for domestic and international audits. Responsibilities Lead and participate in GxP (GMP / GDP / GLP / GVP) compliance audits. Author, review and approve audit reports. Assess the effectiveness of corrective actions in response to internal and external audits and negotiate improved CAPA plans with audit stakeholders. Provide compliance oversight to ensure product quality during operations and adherence to applicable global Health Authority regulations, requirements and expectations. Determine and inform Executive Leadership when potential Quality and / or regulatory issues at CMOs may impact product quality, patient safety, supply chain and / or regulatory compliance. Develop, review and approve departmentspecific SOPs and corporate standards in support of the Quality Management System. Communicate department metrics and monitor performance. Serve as a Compliance representative on crossfunctional and multisite teams and provide compliance interpretation of GxP to clinical and commercial operations. Lead and partner with external contract organizations and internal stakeholder departments to drive continuous improvement of audit processes, procedures and product quality. Foster an environment of accountability, diversity and speaking up. Effectively collaborate with internal operations and external third parties to execute. Requirements Bachelors Degree is required in Biological Science, Chemistry or related technical discipline. 10 years of experience in the Biotech / Pharmaceutical industry. Strong working knowledge and interpretation of FDA, EMA, MHRA, ICH and other global regulations and guidelines. Experience with GxP auditing practices and methodology. Familiarity with all phases of biologic / gene therapy / mRNA drug development. Demonstrates high personal and professional ethical standards. Experience with computerized systems and compliance requirements. Broad and direct experience with regulatory authority inspections including both FDA and EMA inspections is a plus. Experience working with contract manufacturing, laboratory and distribution organizations is a plus. Strong organizational and project management skills with a track record of meeting goals / objectives. Flexible work schedule to accommodate program priorities and international activities as needed. This is a Flex role which will typically require onsite work 23 days each week or more depending on business needs with up to 50% travel both domestic and international required. Salary & Benefits Annual salary range: $214,100 - $264,500 USD. Benefits include: Generous vacation time and public holidays observed by the company. Volunteer days. Longterm incentive and Employee stock purchase plans or equivalent offerings. Employee wellbeing benefits. Fitness reimbursement. Tuition sponsorship. Professional development plans. EEO Statement 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. See our CCPA Employee and Applicant Privacy Notice. Other Legal Notice 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. Recruiter Note 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 or hiring managers directly in an attempt to solicit business. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Inquiries on developing a recruiting relationship with us may be directed to Talent Acquisition. #J-18808-Ljbffr