Remote Executive Director, Global R&D Quality

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

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a global team across US, Asia, Europe and North America.

This role ensures inspection readiness, oversees clinical trial and submission support, and drives the R&D audit program and data integrity across affiliates. The leader will set strategic direction for Global Quality, including GCQ, CSV and GPV, partner with business groups to harmonize processes, and identify quality risks from development

Qualifications

• Bachelor’s degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment.
• Strong knowledge of current global Good Clinical Practice (GCP) for designing, recording and reporting trials.
• Experience with audits and regulatory inspections.
• Experience with Japanese company or multinational with Japanese arm.
• Working knowledge of current Good Manufacturing Practice (cGMP) regulations.
• Strong project management, leadership, problem solving, and organization skills.
• Travel approximately 30%.

Responsibilities

• Inspire and develop a team of Quality professionals and deliver the Global Quality strategy.
• Ensure internal and external sites are inspection ready and CAPAs are implemented.
• Lead clinical facility and system audits and ensure corrective actions are documented.
• Establish standards and procedures to ensure quality and compliance across business units.

Education

Bachelor’s degree in a relevant field

Job description

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a global team across US, Asia, Europe and North America.

This role ensures inspection readiness, oversees clinical trial and submission support, and drives the R&D audit program and data integrity across affiliates. The leader will set strategic direction for Global Quality, including GCQ, CSV and GPV, partner with business groups to harmonize processes, and identify quality risks from development