Global GVP Compliance Lead - Quality & Inspection Readiness

Takeda Pharmaceutical Co.; Glattbrugg; Vor Ort; CHF 141.000 - 194.000; Vollzeit

Zusammenfassung

Takeda Pharmaceutical Co. in Zurich is seeking a GVP Quality & Compliance specialist to strengthen the global GVP framework by operating a risk-based, scalable QMS across the pharmacovigilance system.

You will apply root‑cause analysis, support CAPA lifecycle, and prepare for inspections while aligning PVAs, PSMF and regulatory docs with PSPV. You will contribute to global GVP oversight, governance forums and audits, working closely with cross‑functional teams to ensure regulatory alignment and

Qualifikationen

• Experience in global pharmaceutical PV and quality/compliance roles.
• Strong knowledge of ICH E2 and GVP directives and modules.
• Ability to work in cross‑functional, matrixed environments.

Aufgaben

• Support operation and maintenance of the GVP Quality Management System (QMS) with standards, policies and procedures.
• Execute core GVP quality system processes including change control, deviations, investigations and CAPA management.
• Support investigations of significant GVP quality events applying root‑cause analysis.
• Assist CAPA lifecycle management and timely action tracking across audits and inspections.
• Support GVP inspection readiness activities and collaborative responses to inspections.
• Contribute to quality oversight of PV suppliers and PVAs alignment with Takeda standards.

Kenntnisse

PV/Quality experience

GVP regulations knowledge

Cross-functional collaboration

Problem solving

Ausbildung

BSc in Science/Health

Master's/PhD preferred

Jobbeschreibung

Takeda Pharmaceutical Co. in Zurich is seeking a GVP Quality & Compliance specialist to strengthen the global GVP framework by operating a risk-based, scalable QMS across the pharmacovigilance system.

You will apply root‑cause analysis, support CAPA lifecycle, and prepare for inspections while aligning PVAs, PSMF and regulatory docs with PSPV. You will contribute to global GVP oversight, governance forums and audits, working closely with cross‑functional teams to ensure regulatory alignment and