Senior GVP Quality & Compliance Lead

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

Job summary

Takeda in Zurich, Switzerland, invites a seasoned GVP Quality & Compliance professional to strengthen the global PV compliance framework. You will operate the GVP QMS, support CAPA, root-cause analyses, and inspection readiness within PSPV, aligning with global regulatory expectations.

You will partner with cross-functional teams to oversee PV supplier quality, PVAs, and the PSMF, ensuring regulatory alignment and robust governance across Takeda’s pharmacovigilance system.

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 including ICH, EMA GVP, CFR, REMS, GPSP, and WHO guidance.

Responsibilities

• Manage and support the operation of the GVP Quality Management System (QMS) by executing review, implementation, and maintenance of standards, policies, and procedures supporting GVP-regulated activities within PSPV.
• Execute core GVP quality system processes including change control, deviations and investigations, incident notification and escalation, and CAPA management, acting as a GVP compliance subject-matter expert.
• Support investigations of significant GVP quality events and deviations, applying root-cause analysis to support remediation and prevention of recurrence.
• Support CAPA lifecycle management, including tracking implementation and effectiveness, monitoring actions, and escalation of risks.
• Support GVP inspection readiness activities, including preparation, coordination, document support, and execution of inspections.

Skills

PV compliance

Quality management

Regulatory knowledge

GVP directives

Audits & inspections

CAPA management

Risk analysis

Cross-functional collaboration

Regulatory intelligence

Communication skills

Education

BSc in science/ allied health

Job description

Takeda in Zurich, Switzerland, invites a seasoned GVP Quality & Compliance professional to strengthen the global PV compliance framework. You will operate the GVP QMS, support CAPA, root-cause analyses, and inspection readiness within PSPV, aligning with global regulatory expectations.

You will partner with cross-functional teams to oversee PV supplier quality, PVAs, and the PSMF, ensuring regulatory alignment and robust governance across Takeda’s pharmacovigilance system.