Global R&D Quality Executive Leader

Otsuka Pharmaceutical Co., Ltd.

United States

On-site

USD 250,000 - 388,000

Full time

3 days ago

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Job summary

Otsuka Pharmaceutical Co., Ltd. seeks an experienced Executive Director of R&D Global Quality to lead a global team and ensure inspection readiness across R&D, with responsibility for GCQ, CSV and GPV functions.

The role reports to senior management with dotted lines to Asia/Europe and requires strong regulatory engagement and risk management. The position focuses on coordinating quality systems, audits, and data integrity across development through commercial distribution, with a strategic

Qualifications

Bachelor's degree and 15+ years in FDA-regulated pharmaceutical/medical device environments.
Strong knowledge of GCP for designing, recording and reporting trials.
Experience with external service providers and working with Japanese/ multinational with Japanese arm.
Working knowledge of cGMP regulations.
Travel approximately 30%.

Responsibilities

Inspire and develop a QA team; partner with stakeholders and help deliver Global Quality strategy.
Ensure sites are inspection ready; manage inspections and CAPA responses.
Lead clinical facility and system audits; communicate results and implement corrective actions.
Establish standards and procedures for quality management and risk mitigation across GQ.
Oversee vendor management and Management Review processes.