Senior Director, Global Inspection Management

Position Summary:

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We are seeking 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 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 deep 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:

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 pro