Job Details

Overview

Be a hero for our rare disease patients. Ultragenyx is focused on leading the future of rare disease medicine by applying science, accelerating development, and collaborating to reach patients with meaningful treatments. We strive to create a supportive and inclusive environment for our people, with opportunities for learning and growth.

Position Summary

Senior Director of GMP Inspection Management to lead the development and implementation of a global inspection readiness and management program. Responsibilities include strategic direction of inspection management across the Ultragenyx network, ensuring proactive and risk-based readiness for internal manufacturing, testing operations, and external CMOs. Ideal candidate has deep GMP, regulatory inspections, and cross-functional collaboration experience to drive 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. Locations vary; the business will set onsite days for Flex employees.

Responsibilities

• Global Inspection Strategy & Readiness
  • Design and implement a comprehensive global GMP inspection management framework and governance
  • Lead inspection readiness initiatives across internal and external manufacturing and testing sites
  • Develop and maintain inspection storyboards / playbooks, mock inspection protocols, and response templates
  • Develop and monitor inspection management and readiness performance metrics
• Inspection Execution & Management
  • Serve as the global lead for regulatory GMP inspections (FDA, EMA, PMDA, etc.) including hosting coordination and response management
  • Oversee inspection logistics, real-time support, and post-inspection follow-up activities
  • Ensure timely and effective CAPA development and implementation
• External Manufacturing Oversight
  • Partner with Quality, Manufacturing, and Supply Chain teams to ensure CMO sites are inspection ready
  • Conduct inspection readiness assessments and support CMOs during regulatory inspections
  • Harmonize inspection practices and expectations across external partners
• Training & Continuous Improvement
  • Develop and deliver inspection training programs for SMEs and site leadership
  • Analyze inspection trends and regulatory intelligence to inform risk mitigation strategies
  • Drive continuous improvement in inspection readiness processes and tools
• Leadership & Collaboration
  • Lead cross-functional inspection readiness teams and governance forums
  • Collaborate with Global Quality, Regulatory Affairs and Compliance teams to align on inspection strategy
  • Represent the company in external forums and industry groups as appropriate

Requirements

• Bachelors degree in Life Sciences or related field; advanced degree preferred
• 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
• Excellent communication, leadership, and project management skills
• 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 50% travel may be required (domestic and international)

Compensation & Benefits

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

250000 - $309800 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 our CCPA Employee and Applicant Privacy Notice.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of 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. 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.