Associate Director, Global Inspection Management

Position Summary:

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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 of a comprehensive global GMP inspection management framework and governance
• Support inspection readiness initiatives across internal and external manufacturing and testing sites
• Develop and maintain inspection storyboards/playbooks, mock inspection protocols, and response templates
• Monitor and report inspection management and readiness performance metrics
• Support regulatory GMP inspections (FDA, EMA, PMDA, etc.), including coordination, and response management as needed
• Oversee inspection logistics, real-time support, and post-inspection follow-up activities
• Partner with Quality, Manufacturing, and Supply Chain teams to ensure CMO sites are inspection ready
• Participate in inspection readiness assessments and support CMOs during regulatory inspections
• Deliver inspection training programs for SMEs and inspection teams
• Analyze inspection trends and regulatory intelligence to inform risk mitigation strategies
• Drive continuous improvement in inspection readiness processes and tools.
• Participate in cross-functional inspection readiness teams and governance forums.
• Collaborate with Global Quality, Regulatory Affairs, and Compliance teams to align on inspection 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
• Excellent communication 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 be required (Domestic and International)

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