Global PV Quality & Compliance Lead

argenx; United States; Presencial; USD 180.000 - 240.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual incentives

Descripción de la vacante

argenx is seeking a Global Patient Safety (GPS) Pharmacovigilance Quality Management (PV QM) Lead to implement the QMS across the GPS organization and oversee third-party PV obligations. The role requires driving quality, training, and process improvements in a global biotech setting.

Based in the US/Belgium/Switzerland, you will lead audits, CAPA activities, document control (Veeva), and KPI development, coordinating with cross-functional teams to ensure regulatory readiness and continuous

Formación

• Bachelor’s degree in pharmacy, nursing, healthcare or life-science or country equivalent.
• At least 10 years of experience in the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance/drug safety.
• Proven track record of establishing or managing pharmacovigilance quality systems, processes and teams.
• Robust experience with preparing for, hosting and responding to audits and regulatory inspections globally.
• Solid knowledge of pharmacovigilance regulatory requirements across Europe, US and Japan.

Responsabilidades

• Coordinate GVP audit & inspection activities.
• Actively engage in internal global GVP audits and inspection readiness activities.
• Prepare GPS team members for inspection readiness and ensure documentation is readily retrievable.
• Coordinate and prepare GPS responses to audit and inspection findings.
• Coordinate development and monitoring of CAPA and deviations.
• Develop, deliver, and maintain pharmacovigilance training and GPS procedural documents.

Conocimientos

Fluency in English

Global collaboration

Project management

Training & coaching

Audits & inspections

Documentation writing

Vendor management

Educación

Bachelor’s degree in pharmacy, nursing, healthcare or life-science

Herramientas

Veeva System

MS Office

Descripción del empleo

argenx is seeking a Global Patient Safety (GPS) Pharmacovigilance Quality Management (PV QM) Lead to implement the QMS across the GPS organization and oversee third-party PV obligations. The role requires driving quality, training, and process improvements in a global biotech setting.

Based in the US/Belgium/Switzerland, you will lead audits, CAPA activities, document control (Veeva), and KPI development, coordinating with cross-functional teams to ensure regulatory readiness and continuous