Global GVP Compliance Lead – Quality & Inspections

Takeda; Zürich; On-site; CHF 141,000 - 194,000; Full time

Job summary

Takeda in Zurich seeks a GVP Quality & Compliance expert to strengthen the global GVP framework and maintain a scalable, compliant PV quality system. You will ensure alignment with GVP regulations and Takeda standards across the pharmacovigilance system.

Partner with PSPV and CI teams to enhance risk-based quality oversight, contribute to inspection readiness, supplier governance, PVAs, and PSMF governance. Strong communication and analytical skills are essential.

Qualifications

• Scientific or allied health qualification (BSc required; Master’s/PhD strongly preferred).
• Experience (5+ years) in the global pharmaceutical industry in PV and Quality and Compliance roles (3+ years).
• Strong knowledge of pharmacovigilance regulations (ICH, GVP, CFR, REMS, GPSP).
• Experience supporting GVP audits/regulatory inspections, investigations and remediation.

Responsibilities

• Operate the GVP Quality Management System by reviewing, implementing, and maintaining standards, policies, and procedures.
• Execute core GVP quality processes including change control, deviations, investigations, CAPA management, and incident escalation.
• Support investigations of GVP quality events using root-cause methodologies for remediation and recurrence prevention.
• Oversee CAPA lifecycle tracking, action completion, and risk escalation in audits and inspections.
• Support GVP inspection readiness activities: preparation, coordination, and document support.
• Assist with regulatory inspections regarding PVAs and PSMF in collaboration with stakeholders.
• Contribute to supplier quality governance and escalation of compliance risks with PSPV.
• Provide GVP input to PVAs and ensure alignment with Takeda standards and regulations.
• Contribute data to the Pharmacovigilance System Master File (PSMF) and ensure coherence with PV agreements.
• Support responses to regulatory authority requests related to PSMF and PVAs with cross-functional teams.
• Prepare inputs for Management Review and Clinical & Safety Quality Council on GVP compliance.
• Support internal and external audits across Takeda’s PV system and CAPA follow-up.

Skills

GVP Knowledge

PV Compliance

Audits & Inspections

Root Cause Analysis

Regulatory Knowledge

Cross-functional teamwork

Writing & Communication

Integrity & Patient Focus

Education

Bachelor’s degree in Science

Master’s/PhD preferred

Job description

Takeda in Zurich seeks a GVP Quality & Compliance expert to strengthen the global GVP framework and maintain a scalable, compliant PV quality system. You will ensure alignment with GVP regulations and Takeda standards across the pharmacovigilance system.

Partner with PSPV and CI teams to enhance risk-based quality oversight, contribute to inspection readiness, supplier governance, PVAs, and PSMF governance. Strong communication and analytical skills are essential.