Senior Director, Global PV Quality

Argenx; Zürich; On-site; CHF 180,000 - 260,000; Full time

Job summary

argenx is seeking a Global Patient Safety PV QM Lead to implement and maintain the PV QMS globally. You will oversee third-party PV contractual obligations, drive training programs, and manage procedural documents in collaboration with the Director, GPS Quality Management.

The role requires extensive PV quality system experience, audits/inspections expertise, and the ability to lead a cross-functional team across geographies. Location flexibility includes Belgium, Switzerland or the US.

Qualifications

• Bachelor’s degree in pharmacy or life sciences is required.
• 10+ years in pharma/biotech with 5+ years in PV/drug safety.
• Experience establishing or managing PV quality systems.

Responsibilities

• Coordinate GPV audit & inspection activities and readiness.
• Lead CAPA and deviation management to prevent recurrence.
• Develop and manage GPS training programs and documentation.
• Monitor KPI development, SOP compliance, and PVAs/SDEAs with partners.
• Collaborate with GPS leadership to ensure cross-functional alignment.

Skills

PV Quality Systems

Audits & Inspections

Documentation / SOPs

Cross-functional collaboration

English proficiency

Education

Bachelor’s degree in pharmacy or life sciences

Master’s degree in life sciences (advantageous)

Tools

Veeva System

Job description

argenx is seeking a Global Patient Safety PV QM Lead to implement and maintain the PV QMS globally. You will oversee third-party PV contractual obligations, drive training programs, and manage procedural documents in collaboration with the Director, GPS Quality Management.

The role requires extensive PV quality system experience, audits/inspections expertise, and the ability to lead a cross-functional team across geographies. Location flexibility includes Belgium, Switzerland or the US.