Global R&D Quality Director – Remote

Otsuka America Pharmaceutical Inc.; Jackson (MS); Remote; USD 250,000 - 388,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. seeks an Executive Director of R&D Global Quality to lead a global team focused on R&D quality, overseeing GCQ, CSV, and GPV across affiliates.

This role partners with regions to ensure end-to-end quality, process harmonization, and risk mitigation from development to distribution. The leader will drive a compelling quality vision, provide strategic direction, and ensure inspection readiness, regulatory engagement, and data integrity across clinical and

Qualifications

• Bachelor’s degree and 15+ years of FDA regulated pharma/medical device experience.
• Strong knowledge of GCP in designing, recording and reporting trials and regulatory inspections.
• Experience with external service providers and global quality programs.

Responsibilities

• Inspire and develop a QA team; partner with stakeholders to deliver Global Quality strategy.
• Ensure sites are inspection ready; manage health authority inspections and CAPA effectiveness.
• Lead clinical facility and system audits across sites, CROs, and vendors with timely corrective actions.
• Establish standards and procedures for quality management, risk mitigation, and compliance.
• Report quality performance to senior management through Management Review.

Skills

Leadership

Quality systems

Regulatory engagement

Auditing

Project management

Cross-functional collaboration

Education

Bachelor’s degree

Job description

Otsuka America Pharmaceutical Inc. seeks an Executive Director of R&D Global Quality to lead a global team focused on R&D quality, overseeing GCQ, CSV, and GPV across affiliates.

This role partners with regions to ensure end-to-end quality, process harmonization, and risk mitigation from development to distribution. The leader will drive a compelling quality vision, provide strategic direction, and ensure inspection readiness, regulatory engagement, and data integrity across clinical and