Associate Director, Global Inspection Management

About the role

This role leads global inspection readiness and management for Ultragenyx Pharmaceutical. The position coordinates responses to authorities such as FDA, EMA, and PMDA.

Leaders set direction and build the conditions for their teams to succeed. They hire, coach, and hold people accountable. Leadership work spans strategy, communication, and decision making. Effective leaders give clear context and remove obstacles for the people who report to them. Leadership roles are measured by team outcomes, retention, and delivery. Most organizations expect leaders to be visible, predictable, and generous with context.

Key facts

What you'll do

A global inspection management framework and governance are implemented and advanced to strengthen regulatory readiness.

Performance metrics for inspection management and readiness are monitored and reported to guide risk-focused inspection activities.

Inspection logistics are overseen, with real-time support provided and post-inspection follow-up managed to ensure smooth audit execution.

Inspection readiness assessments are conducted, and CMOs are supported during regulatory inspections with adjustments based on findings.

SMEs and inspection teams receive training programs that build internal capability and strengthen execution across the network.

Inspection trends and regulatory intelligence are analyzed to define and implement risk mitigation strategies that reduce exposure.

Inspection readiness processes and supporting tools drive continuous improvement through input from quality and operations teams.

Cross-functional inspection readiness teams and governance forums participate to align strategies and ensure consistent communication.

Requirements

A Bachelor's degree in Life Sciences or a related field is required as a baseline qualification.

Experience of 12+ years in GMP compliance, quality assurance, or regulatory affairs within the biopharmaceutical industry is required.

A proven track record of leading global regulatory inspections and readiness programs must be demonstrated.

Strong knowledge of global GMP regulations and inspection practices across key jurisdictions is necessary.

Experience managing both internal operations and oversight of external manufacturing sites is required.

Excellent communication and project management skills are needed to handle complex initiatives.

The ability to influence across levels and functions within a matrixed organization is essential.

Experience with biologics or gene therapy manufacturing methods and considerations is expected.

Prior experience working with global CMOs and managing complex supply chain requirements is required.

Familiarity with digital tools for inspection management and quality systems is required.

Up to 25% travel may be required, including domestic and international destinations as needed.

Practical notes

The role typically requires onsite work 2-3 days per week, with schedules adjusted based on business needs. Ultragenyx is an equal opportunity employer and provides reasonable accommodation for protected statuses. Typical interview steps

Leadership hiring usually includes a strategy case, a people scenario, and a values conversation. Candidates may be asked to turn around a struggling team or plan for growth. Past results are examined closely, especially how decisions were made. Interviewers dig into specific decisions you made and their consequences. Preparing two or three decision stories with numbers and lessons is the best use of time.

Good to know

The role involves frequent interaction with regulatory inspections and cross-functional quality and manufacturing teams. It requires experience with risk-based inspection readiness and trend analysis. The position uses digital tools for managing inspection workflows and quality systems. Travel may include domestic and international destinations. Success depends on strong influence and collaboration in a matrixed environment.

Career growth

Leadership careers move from manager to senior manager, director, and executive roles. Each step adds more scope and more responsibility for outcomes. The best leaders keep learning how to delegate, communicate, and decide. Leadership careers reward a record of building and developing people. The higher you go, the more your communication shapes the whole organization.