Senior Manager, GVP Compliance

Takeda Pharmaceutical Co.; Glattbrugg; On-site; CHF 141,000 - 194,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

PV/Quality experience

GVP regulations knowledge

Cross-functional collaboration

Problem solving

Education

BSc in Science/Health

Master's/PhD preferred

Job description

About the role

Strengthen key elements of the global Good Pharmacovigilance Practice (GVP) compliance framework by executing and maintaining a risk‑based, digitally enabled quality system that is compliant, scalable, and sustainable across Takeda’s pharmacovigilance system. Contribute to the implementation of an integrated GVP compliance approach in close partnership with the PSPV function and the Center for Continuous Improvement for CTD and PV, supporting aligned quality oversight and effective adoption of regulatory intelligence. Support the effectiveness of GVP investigations, audits, and inspections by applying robust root‑cause analysis, supporting CAPA execution and compliance monitoring, and contributing to global GVP inspection readiness activities. Contribute to effective GVP quality governance by supporting monitoring and reporting of GVP compliance risks, trends, and mitigation actions through PSPV governance forums, the R&D Quality risk register, and the Clinical & Safety Quality Council.

How you will contribute

• 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 methodologies to support effective remediation and prevention of recurrence.
• Support CAPA lifecycle management, including tracking implementation and effectiveness, monitoring timely completion of actions related to quality events, audits, and inspections, and escalating risks where appropriate.
• Support GVP inspection readiness activities, including preparation, coordination, document support, and execution of inspection activities using established processes and available technologies.
• Support assigned GVP regulatory inspections, including inspection preparation, hosting support, response development, tracking of commitments, risk escalation, and mitigation activities in collaboration with cross‑functional stakeholders.
• Support strategic quality oversight of PV suppliers, including review of Quality Agreements, participation in supplier governance activities, and escalation of identified compliance risks in partnership with PSPV.
• Provide GVP compliance review and quality input to Pharmacovigilance Agreements (PVAs), ensuring alignment with applicable global GVP regulations and Takeda standards, and escalating identified gaps, risks, or ambiguities to senior GVP Compliance leadership as appropriate.
• Contribute GVP quality and compliance data to the Pharmacovigilance System Master File (PSMF), supporting the accurate reflection of Takeda’s pharmacovigilance system, processes, governance, and oversight framework.
• Ensure consistency between PSPV quality system documentation, PVAs, and the PSMF, identifying inconsistencies or emerging risks and supporting corrective actions to maintain regulatory alignment and inspection readiness.
• Support responses to regulatory authority requests related to the PSMF and PVAs, including preparation of supporting documentation and evidence in collaboration with PSPV, R&D Quality, and Global Regulatory stakeholders.
• Contribute to quality governance activities, including preparation of materials and inputs for Management Review and the Clinical & Safety Quality Council related to GVP compliance.
• Provide support for Global Quality internal audits and Business Alliance audits across Takeda’s pharmacovigilance system, including preparation, coordination, response support, and CAPA follow‑up.

Skills and 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 working knowledge and understanding of pharmacovigilance regulations including ICH Pharmacovigilance Guidelines (E2 Series), EMA Good Pharmacovigilance Practices (GVP) Directives and Modules, US Code of Federal Regulations (CFR), FAERS and Risk Evaluation and Mitigation Strategies (REMS), Japan PMDA & MHLW GVP Ordinance and Good Post‑Marketing Study Practice (GPSP) Ordinance, Health Canada, World Health Organization (WHO) global multinational framework for International Drug Monitoring and those in countries such as China (NMPA PV), India (PvPI), etc.
• Experience in supporting GVP audits and regulatory inspections, investigations and remediation.
• Strong attention to detail with a quality and compliance mindset.
• Ability to operate effectively in cross‑functional, matrixed environments.
• Solid analytical and problem‑solving skills.
• Clear written and verbal communication skills.
• Ability to manage priorities and execute under timelines.
• Professional judgment with willingness to elevate risks appropriately.
• Integrity‑driven and patient‑focused approach aligned with Takeda values.

Locations

Zurich, Switzerland

Base Salary Range: CHF141,100.00 - CHF194,040.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

Worker Type

Employee Worker Sub-Type Regular Time Type Full time

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Takeda is an equal opportunity employer.