Associate Director, GCP Compliance (Japan)
Takeda Pharmaceutical Company(4 months ago)
About this role
A regional GCP Compliance Manager at Takeda leads compliance management for clinical trial delivery, focusing on implementation of regional quality event handling, internal audits, and inspection readiness. The role provides regional expertise on GCP inspection strategy and TMF oversight while developing risk-based compliance assessments and KPIs. It also involves mentoring staff and collaborating across functions and geographies to ensure adherence to global and local regulations.
Required Skills
- GCP Compliance
- Compliance Management
- Audit Readiness
- CAPA Management
- Risk Assessment
- TMF Oversight
- KPI Reporting
- Stakeholder Management
- Root Cause Analysis
- Team Leadership
Qualifications
- Bachelor's Degree
About Takeda Pharmaceutical Company
takeda.comTakeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.
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