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.

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.

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.

• Support the implementation ofa comprehensive global GMP inspection management framework and 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.),including coordination, and response management as 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 and inspection 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.

• 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…