Senior GVP Compliance Lead

Takeda Pharmaceuticals International AG; Glattbrugg; Presencial; CHF 150.000 - 190.000; Jornada completa

Descripción de la vacante

Takeda Pharmaceuticals International AG in Switzerland seeks a Senior Manager, GVP Compliance to strengthen the global GVP compliance framework, maintaining a risk-based, digitally enabled quality system across Takeda’s pharmacovigilance.

You will partner with PSPV and the Center for Continuous Improvement for CTD and PV alignment and support regulatory intelligence adoption, ensuring inspection readiness and robust CAPA management.

Formación

• Bachelor’s degree in a scientific or allied health field.
• 5+ years in PV and Quality and Compliance roles (3+ years in industry).
• Strong knowledge of pharmacovigilance regulations (ICH E2, EMA GVP, CFR, REMS, GPSP).
• Experience supporting GVP audits and regulatory inspections.
• Detail-oriented with a quality mindset.
• Ability to operate in cross-functional, matrixed environments.
• Clear written and verbal communication.
• Able to manage priorities and timelines.

Responsabilidades

• Strengthen GVP compliance framework and maintain a scalable QMS.
• Support CAPA lifecycle, investigations, and risk-based monitoring.
• Assist GVP inspection readiness and regulatory responses.
• Oversee PV supplier governance and PVAs alignment.
• Contribute to PSMF accuracy and alignment with PVS framework.
• Support Management Review and Clinical & Safety Quality Council inputs.

Conocimientos

GVP Compliance

Pharmacovigilance

Quality Assurance

Cross-functional

Analytical thinking

Communication skills

Prioritization

Educación

Bachelor's degree

Master’s/PhD preferred

Descripción del empleo

Takeda Pharmaceuticals International AG in Switzerland seeks a Senior Manager, GVP Compliance to strengthen the global GVP compliance framework, maintaining a risk-based, digitally enabled quality system across Takeda’s pharmacovigilance.

You will partner with PSPV and the Center for Continuous Improvement for CTD and PV alignment and support regulatory intelligence adoption, ensuring inspection readiness and robust CAPA management.