Remote Global R&D Quality Executive Leader

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

Job summary

Otsuka America Pharmaceutical Inc. is seeking an experienced Executive Director of R&D Global Quality to lead a global QA team focused on development-stage quality across sites and affiliates.

The role requires driving inspection readiness, managing audits, and engaging with regulatory authorities to ensure data integrity and risk mitigation from development through distribution. The leader will provide strategic direction for Global Clinical Quality, CSV, and GPV, while aligning QA activities

Qualifications

• Bachelor's degree in a life sciences field and 15+ years in FDA-regulated pharma or medical device environments.
• Strong knowledge of current Good Clinical Practice and audit techniques for regulatory inspections.
• Experience collaborating with Japanese affiliates or multinational groups with Japanese business units.

Responsibilities

• Inspire and develop a QA team, partnering with key stakeholders to deliver GQ strategy.
• Ensure inspection readiness across clinical trials, PV operations, and sites.
• Lead audits, corrective actions, and data integrity initiatives across global operations.
• Develop and maintain quality management systems, policies, and risk mitigation processes.
• Oversee vendor management, budgeting, and management reviews for continuous improvement.

Skills

Executive leadership

Quality management

GCP/GxP knowledge

Regulatory liaison

Audit management

Budget management

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Tools

GxP systems

Job description

Otsuka America Pharmaceutical Inc. is seeking an experienced Executive Director of R&D Global Quality to lead a global QA team focused on development-stage quality across sites and affiliates.

The role requires driving inspection readiness, managing audits, and engaging with regulatory authorities to ensure data integrity and risk mitigation from development through distribution. The leader will provide strategic direction for Global Clinical Quality, CSV, and GPV, while aligning QA activities