Associate Director, International GVP Compliance

Takeda Pharma AG seeks an Associate Director for International GVP Compliance in Zürich. The role focuses on implementing global pharmacovigilance standards, leading audits, and ensuring regional inspection readiness across international operations.

This position acts as a central compliance advisor and subject matter expert, bridging global strategies with regional execution. The incumbent partners with Local Operating Companies and global teams to foster a risk-based, inspection-ready pharmacovigilance culture while ensuring consistent adherence to regulatory standards across assigned international territories.

Responsibilities

• Translate global GVP strategies into consistent regional practices, ensuring uniform application of regulations and company standards across Local Operating Companies.
• Serve as the regional expert on GVP compliance, guiding stakeholders on regulatory expectations, quality system mandates, and preparation for inspections.
• Oversee core Quality System processes, including the management of deviations, investigations, CAPA, change control, and necessary escalations.
• Direct high-quality investigations and root-cause analyses with a primary focus on patient safety and preventing recurring issues.
• Monitor CAPA development and effectiveness, escalating systemic risks or delays to regional leadership as needed.
• Embed inspection readiness into daily pharmacovigilance operations and manage regional readiness activities.
• Lead audits and regulatory inspections at both regional and Local Operating Company levels, supporting preparation, conduct, and follow-up actions.
• Collaborate with the Director of Regional GVP Compliance and regional PV leaders to align inspection messaging and track corrective actions.
• Proactively identify and assess regional compliance risks by analyzing audit results, inspection findings, and key quality indicators.
• Provide regional insights to governance forums and support the preparation of materials for Management Review and Safety Quality Councils.
• Ensure timely escalation of critical compliance issues, offering analysis and recommendations to regional leadership.
• Drive continuous improvement efforts based on regulatory feedback, audit trends, and quality analytics.

Requirements

• A Bachelor of Science (BSc) degree in a scientific or allied health field is mandatory.
• Minimum of seven years of experience within the pharmaceutical or healthcare sector.
• At least four years of experience in Pharmacovigilance Quality, Compliance, or PV operational roles.
• Deep working knowledge of GVP regulations, including EU GVP Modules, ICH E2 guidelines, US CFR, and regional authority expectations.
• Proven experience supporting GVP audits, regulatory inspections, investigations, and remediation activities.

Nice to have

• An advanced degree is preferred.

About the company

Takeda is a global top employer dedicated to improving people's health through innovation and top performance. The company fosters an inclusive, collaborative, and international work environment grounded in its core values: Integrity, Fairness, Honesty, and Perseverance. Roles are awarded based on merit, welcoming candidates from all backgrounds.

• Strong commitment to diversity, equity, and inclusion.
• Merit-based roles open to all genders, ages, beliefs, orientations, races, and abilities.
• Core values include Integrity, Fairness, Honesty, and Perseverance.
• Global top employer offering exciting career paths and promoting innovation.
• Inclusive, collaborative, and international work environment.