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Position Summary:
- Accountable for strategic leadership and operational effectiveness of global PV Operations, Quality & Compliance.
- Ensures PV system scalability, compliance, and inspection readiness for portfolio growth.
- Directs case processing, vendor oversight, PSMF management, and quality/compliance systems.
Responsibilities:
- Build and mentor the global PV function, aligning with corporate long-range growth plans.
- Lead PV operations including intake, triage, case processing, and regulatory reporting.
- Oversee vendor governance, safety agreements, and partner compliance.
- Manage PV quality systems, deviations, CAPAs, audits, and inspection preparedness.
Qualifications:
- Minimum 15 years of global DSPV experience with advanced scientific degree.
- Direct experience in PV Operations, vendor management, and GVP quality/compliance in biopharma.
- Proven leadership of global teams and cross-functional collaboration.
- Experience with FDA/EMA inspections and PV system governance.
Benefits:
- Generous vacation time and public holidays observed by the company.
- Long term incentive and Employee stock purchase plans.
- Employee wellbeing benefits, fitness reimbursement, and tuition sponsoring.
- Professional development plans and volunteer days.
Ultragenyx
Ultragenyx is a biopharmaceutical company focused on developing life-changing treatments for rare diseases. They foster a supportive and inclusive culture of learning and growth, aiming to be an organization where employees can thrive personally and professionally.