Senior Director, Global Inspection Management

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.

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 dedicated – Your biggest challenges yield rare possibilities

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.

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.

• 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.

• 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.

• 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.