Global PV Operations & Quality Lead — Remote

Ultragenyx; United States; Remote; USD 301,000 - 372,000; Full time

Benefits offered by this job

Vacation time

Volunteer days

Stock purchase plans

Wellbeing benefits

Job summary

Ultragenyx is seeking an Executive Director, Head of Global Pharmacovigilance Operations, Quality & Compliance to lead its PV operations, QA, and compliance worldwide. This role drives strategy, vendor governance, and inspection readiness to support portfolio growth and regulatory success.

The position is remote with occasional travel to offices as needed. You will oversee global case processing, TMF support, and training programs, and work across Clinical Development, Regulatory, and Commercial

Qualifications

• Bachelor's degree with advanced degree in a scientific field.
• Healthcare professional degree preferred (PharmD, RPh, RN/BSN, MPH).
• 15+ years global DSPV experience in PV operations.

Responsibilities

• Lead global PV operations and ensure inspection readiness.
• Oversee PV QA/Compliance and TMF activities.
• Manage PV vendor governance and alliance management.
• Prepare for regulatory inspections (FDA/EMA).

Skills

PV Operations

Global leadership

Vendor governance

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree

Advanced degree in science

PharmD or equivalent

Tools

Veeva Vault eTMF

Job description

Ultragenyx is seeking an Executive Director, Head of Global Pharmacovigilance Operations, Quality & Compliance to lead its PV operations, QA, and compliance worldwide. This role drives strategy, vendor governance, and inspection readiness to support portfolio growth and regulatory success.

The position is remote with occasional travel to offices as needed. You will oversee global case processing, TMF support, and training programs, and work across Clinical Development, Regulatory, and Commercial