The Associate Director, International GVP Compliance plays a critical role in ensuring the effective implementation and execution of Good Pharmacovigilance Practice (GVP) compliance across assigned international regions. This position partners closely with Local Operating Companies (LOCs), regional Patient Safety and Pharmacovigilance (PSPV) stakeholders, and Global GVP Compliance teams to translate global compliance strategies into consistent regional practices. The role is responsible for strengthening GVP Quality System execution, driving inspection readiness, leading compliance investigations and CAPA activities, identifying emerging compliance risks, and supporting continuous improvement initiatives that protect patient safety and maintain regulatory integrity.

The Associate

Director serves as a trusted compliance advisor and subject matter expert, helping build a risk-based, inspection-ready pharmacovigilance compliance culture across the region. Takeda may use additional Talent Acquisition technologies and artificial intelligence to support the recruitment process, including video interviewing. Artificial intelligence will be used to support, but not solely determine, applicability for a specific position.

GVP Compliance Leadership Lead within assigned region, implementation of global GVP compliance strategies, ensuring consistent interpretation and application of regulations and Takeda standards across LOCs. Act as a regional GVP compliance subject-matter expert, providing guidance to LOC and regional stakeholders on regulatory expectations, quality system requirements, and inspection readiness. GVP Quality Systems Execute and support core GVP Quality System processes regionally, including deviations, investigations, CAPA management, change control, and escalation.

Lead high-quality investigations and root-cause analysis, ensuring patient-safety focus and effective prevention of recurrence. Track, monitor, and support CAPA development, implementation, and effectiveness, escalating risks, delays,



or systemic issues to regional leadership as appropriate.

Inspection

Readiness, Audits & Inspections Manage regional inspection readiness activities, helping embed readiness into routine PV operations rather than point-in-time preparation. Lead in regional and LOC-level audits and regulatory inspections, supporting preparation, inspection conduct, response development, and follow-up activities. Partner with the Director, Regional GVP Compliance, EU QPPV and PSPV to support aligned inspection messaging, issue tracking, and corrective actions.

Compliance Risk

Management & Governance Drive proactive identification and assessment of regional compliance risks by analyzing audit outcomes, inspection findings, KQIs, and compliance data. Contribute regional insights to risk discussions and governance forums, supporting preparation of materials for Management Review and Clinical & Safety Quality Councils. Ensure consistent, timely escalation of critical compliance issues, providing analysis and recommendations to regional leadership.

Continuous

Improvement & Capability Building Support continuous improvement initiatives driven by regulatory feedback, audit trends, and quality analytics, translating insights into actionable regional improvements. Contribute to the development and refinement of regional training, inspection readiness materials, and compliance guidance, ensuring practicality and regulatory relevance. Support knowledge sharing and harmonization of practices across LOCs to strengthen regional consistency and compliance maturity.

Education &





Experience Scientific or allied health qualification required (BSc); 7+ years of experience in the pharmaceutical or healthcare industry, with 4+ years of experience in Pharmacovigilance Quality, Compliance, or PV operational roles. ~ Experience supporting GVP audits, regulatory inspections, investigations, and remediation activities. Robust analytical and problem-solving skills, with the ability to apply risk-based thinking. Highly organized and detail-oriented, able to manage multiple priorities in a dynamic environment. High ethical standards, resilience, and commitment to patient safety and regulatory compliance. Open-minded, appropriately risk-tolerant, and resilient, demonstrating humility, openness to challenge, and constructive debate. Unwavering integrity and ethical standards, with a strong commitment to patient safety, scientific rigor, and regulatory compliance. short-term and/or long-term incentives subsidies for fitness and internet medical, dental, and vision insurance participation in the Registered Retirement Savings Plan (RRSP) short-term and long-term disability coverage annual vacation entitlement additional paid time off and company holidays une assurance santé incluant la prise en charge des frais médicaux, dentaires et optiques une assurance vie de base ainsi qu’un assurance en cas de décès ou de mutilation accidentels (AD&D;) une participation au Régime enregistré d’épargne-retraite (REER) une couverture en cas d’incapacité de travail temporaire ou prolongée un droit à congés payés annuels, avec jours de vacances, jours de récupération et jours fériés spécifiques à l’entreprise 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.

📌 Associate Director, International GVP Compliance (Toronto)
🏢 Takeda Pharmaceuticals
📍 Toronto