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Job Description
The Associate Director, International GVP Compliance plays a critical role in ensuring the effective implementation and execution of Valuable 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.
Key Responsibilities
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, ensur