Associate Director, International GVP Compliance at Takeda Pharmaceuticals International GmbH — NeverHard

Associate Director, International GVP Compliance The Associate Director is responsible for ensuring the effective implementation and execution of Good Pharmacovigilance Practice (GVP) compliance across assigned international regions. The role partners closely with Local Operating Companies (LOCs), regional Patient Safety and Pharmacovigilance stakeholders, and Global GVP Compliance teams to translate global compliance strategies into consistent regional practices. The Associate Director serves as a trusted compliance advisor and subject matter expert, helping to build a risk‑based, inspection‑ready pharmacovigilance compliance culture across the region. Key Responsibilities GVP Compliance Leadership – Lead within the assigned region, implement global GVP compliance strategies, and ensure consistent interpretation of regulations and Takeda standards across LOCs. Act as a regional GVP compliance subject‑matter expert, providing guidance 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. Inspection Readiness, Audits & Inspections – Manage regional inspection readiness activities, embed readiness into routine PV operations, and lead in regional and LOC‑level audits and regulatory inspections. Support preparation, inspection conduct, response development, and follow‑up activities. 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, and ensure timely escalation of critical compliance issues. Continuous Improvement & Capability Building – Support continuous improvement initiatives driven by regulatory feedback, audit trends, and quality analytics. Contribute to the development and refinement of regional training, inspection readiness materials, and compliance guidance, and promote knowledge sharing across LOCs. Qualifications Scientific or allied health qualification required (BSc); advanced degree preferred. 7+ years of experience in the pharmaceutical or healthcare industry, with 4+ years in Pharmacovigilance Quality, Compliance, or PV operational roles. Strong working knowledge of GVP regulations, including EU GVP Modules, ICH E2 guidelines, US CFR, and key regional authority expectations. Experience supporting GVP audits, regulatory inspections, investigations, and remediation activities. Strong analytical and problem‑solving skills, with the ability to apply risk‑based thinking. Effective collaboration skills, ability to influence without direct authority in matrix environments. Clear written and verbal communication skills, confidence engaging regional and cross‑functional stakeholders. Highly organized, detail‑oriented, able to manage multiple priorities in a dynamic environment. High ethical standards, resilience, and commitment to patient safety and regulatory compliance. Locations: Toronto, Canada Base Salary Range: $160,000.00 - $220,000.00 Benefits: Comprehensive benefits and incentives including medical, dental, vision, life and AD&D insurance, short‑ and long‑term incentives, retirement savings plan with employer match, disability coverage, vacation and paid time off, tuition reimbursement, and well‑being programs. Takeda is an equal opportunity employer. For applicants of U.S and Puerto Rico positions, learn about our commitment to Equal Employment Opportunity (EEO). If you are limited in the ability to use our job application tool or require a reasonable accommodation for a disability, please click here. #J-18808-Ljbffr