Senior Director, Global Inspection Management
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Job Summary
ultradedicated Your biggest challenges yield rare possibilities
We areseeking a dynamic and experienced Senior Director of GMP Inspection Management to lead the development and implementation of a global inspection readiness and management program.The role is accountable for the strategic direction of allinspection management and readiness activities across the Ultragenyx network.This role willbe responsible forensuring consistent proactive and risk-basedinspectionreadiness across internal manufacturing and testing operations as well as external Contract Manufacturing Organizations (CMOs). The ideal candidate will bring deepexpertisein GMP compliance regulatory inspections and cross-functional collaboration to drive a culture of continuous improvement and inspection excellence.
Flex: This role will typically require onsite work 2-3 days each week or more depending on business many locations the business will set certain days each week that Flex employees are required to be onsite.
Global Inspection Strategy & Readiness
- Design and implement a comprehensive global GMP inspection management frameworkand governance.
- Leadinspectionreadiness initiatives across internal and external manufacturing and testing sites.
- Develop andmaintaininspectionstoryboards/playbooks mock inspection protocols and response templates.
- Develop andmonitorinspection management and readiness performance metrics.
Inspection Execution & Management
- Serve as the global lead for regulatoryGMPinspections (FDA EMA PMDA etc.) including hosting coordination and response management.
- Oversee inspectionlogistics real-time support and post-inspection follow-up activities.
- Ensuretimelyand effective CAPA development and implementation.
External Manufacturing Oversight
- Partner with Quality Manufacturing and Supply Chain teams to ensure CMO sites areinspection ready.
- Conductinspectionreadiness 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 ininspectionreadiness processes and tools.
Leadership & Collaboration
- Lead cross-functionalinspectionreadiness 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 asappropriate.
- Bachelors degree in Life Sciences or related field; advanced degree preferred.
- 15 yearsof experience in GMP compliance quality assurance or regulatory affairs within the biopharmaceutical industry.
- Proventrack recordof 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 25%travel may berequired(domestic and international).
#LI-KJ1#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
$241400 - $298200 USD
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 .
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.
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About Company
Ultragenyx is focused on developing first-ever approved treatments for rare and ultrarare diseases and moving the rare disease community forward.
