Global R&D Quality Executive Director (Remote)

Otsuka America Pharmaceutical Inc.; Juneau (AK); 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 QA team focused on development and trial quality.

The leader will guide GCQ, CSV and GPV compliance, ensure inspection readiness across sites, and partner with global regions to harmonize processes from development to distribution. The role requires senior strategic leadership, strong regulatory experience, and ability to drive risk mitigation while balancing global business needs in a

Qualifications

• Bachelor’s degree and 15+ years of FDA-regulated pharmaceutical and/or medical device industry experience.
• Strong knowledge of current global GCP for designing, recording and reporting trials with human subjects.
• Experience engaging with Japanese business, or in a multinational with a Japanese arm.
• Experience working with external service providers in a global setting.
• Working knowledge of cGMP regulations and quality systems.
• Strong leadership, project management, problem solving and collaboration across functions.
• Up to ~30% travel.

Responsibilities

• Inspection Readiness: Ensure continuous inspection readiness across all clinical trial sites and PV operations.
• Audit Management: Plan, execute and follow-up internal and external audits for regulatory compliance.
• Regulatory Authority Engagement: Liaise with regulatory authorities for inspections and findings.
• Data Integrity: Maintain accurate and reliable clinical and PV data through robust QA processes.
• Team Leadership: Lead, mentor and develop a high-performing QA team.
• Stakeholder Partnership: Align QA activities with business goals and regulatory requirements.
• Policy Development: Develop and maintain quality/compliance policies and procedures.
• Vendor Management: Oversee clinical vendor management and oversight.
• Management Review: Conduct R&D Management Reviews per QSR and company requirements.
• Budget Management: Develop and manage departmental budgets.

Skills

Leadership

Strategic thinking

Communication

Team development

Regulatory knowledge

Education

Bachelor’s degree

Job description

Otsuka America Pharmaceutical Inc. seeks an Executive Director of R&D Global Quality to lead a global QA team focused on development and trial quality.

The leader will guide GCQ, CSV and GPV compliance, ensure inspection readiness across sites, and partner with global regions to harmonize processes from development to distribution. The role requires senior strategic leadership, strong regulatory experience, and ability to drive risk mitigation while balancing global business needs in a