Associate Director, Global Inspection Management

Associate Director, Global Inspection Management Bedford, MA 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. Position Summary: ultra curious – Apply your biggest ideas in courageous ways We are seeking a dynamic and experienced Associate Director of GMP Inspection Management to execute a global inspection readiness and management program. The role is accountable for the successful execution of all inspection management and readiness activities across the Ultragenyx network. This role will be responsible for ensuring consistent, proactive, and risk-based inspection readiness across internal manufacturing and testing operations, as well as external Contract Manufacturing Organizations (CMOs). The ideal candidate will bring strong expertise in GMP compliance, regulatory inspections, and cross-functional collaboration to drive a culture of continuous improvement and inspection excellence. 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: Support the implementation ofa comprehensive global GMP inspection management frameworkand governance Supportinspection readiness initiatives across internal and external manufacturing and testing sites Develop andmaintaininspectionstoryboards/playbooks, mock inspection protocols, and response templates Monitor and report inspection management and readiness performance metrics Inspection Execution & Management SupportregulatoryGMPinspections (FDA, EMA, PMDA, etc.),includingcoordination, and response managementas needed Oversee inspection logistics, real-time support, and post-inspection follow-up activities External Manufacturing Oversight Partner with Quality, Manufacturing, and Supply Chain teams to ensure CMO sites are inspection ready Participate ininspection readiness assessments and support CMOs during regulatory inspections Deliver inspection training programs for SMEs andinspection teams Analyze inspection trends and regulatory intelligence to inform risk mitigation strategies Drive continuous improvement ininspectionreadiness processes and tools. Participate incross-functionalinspectionreadiness teams and governance forums. Collaborate with Global Quality, Regulatory Affairs, and Compliance teams to alignoninspection strategy. Requirements: Bachelor’s degree in Life Sciences or related field 12+ years of experience in GMP compliance, quality assurance, or regulatory affairs within the biopharmaceutical industry Proven track record of leading global regulatory inspections and readiness programs Strong knowledge of global GMP regulations and inspection practices Experience with both internal operations and external manufacturing oversight Ability to influence across levels and functions in a matrixed organization Experience with biologics or gene therapy manufacturing Prior experience working with global CMOs and managing complex supply chains Familiarity with digital tools for inspection management and quality systems Up to 25% travel may be required (Domestic and International) 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

$179,600 - $221,900 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. #J-18808-Ljbffr Ultragenyx