Regional Clinical Compliance Lead

Location: Japan - Tokyo
Job Type: Permanent
Salary: 8000000 - 9000000 JPY
Job Function: Regulatory Affairs
Reference: JO-190618-193425
Industry: Life Sciences & Healthcare
Sub-Industry: Pharmaceuticals

Company Overview

Global Pharmaceutical Company

Job Description

(Duties & Responsibilities)
✔ This role will report to the Head of Regional Clinical Compliance, Asia Pacific who is a member of the Global Clinical Compliance & Continuous Improvement (GCC&CI) leadership team under Global Clinical Operations (GCO). Responsibilities will include:
✔ In partnership with the Regional Clinical Operations and Global Quality, support the regional study teams and sites to assure inspection and audit readiness at all times. Lead the implementation of the Quality Audit Plans with on-site support prior to, and during internal audits. Coordinate site and sponsor inspections by Health Authorities as necessary.
✔ In partnership with the Regional Clinical Operations teams, provide appropriate continued oversight to study teams. Work closely with the Clinical Quality and Risk Management team and help implement elements of the Quality Management System: identify emerging and significant risks, provide support for root cause analyses and mitigation strategies, ensure documentation and appropriately notify/escalate to the right level of Governance.
✔ Provide CAPA leadership by coordinating CAPA development and approval, as well as implementation and tracking of effectiveness.
✔ Partner with the Clinical Training, Process and Continuous Improvement organization to identify gaps/needs in training at the regional level, and providing local training support/coordination as needed.
✔ As the scope of Global Clinical Operations includes registrational and non registrational data generation (NRDG), regional clinical compliance activities will span across Phase I through IV studies including Investigator-Sponsored Research and Real World Data Generation. In that context, partner with GCO NRDG teams to enhance GCP compliance for NRDG in partnership with Regional/Country Medical.
✔ Work with management and Global Quality to foster a regional, cross functional mindset of Quality Excellence, Quality by Design, Inspection Readiness at all times, and Growth Mindset.

Requirements

Rich GCP related experience
English(MUST)