Global R&D Quality Executive Director (Remote)

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

Benefits offered by this job

Comprehensive medical benefits

Dental and vision coverage

401(k) match

Paid time off and holidays

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. seeks an Executive Director of R&D Global Quality to lead a global QA team and ensure inspection readiness for clinical and PV operations.

You will drive the global QA strategy, oversee audits, manage regulatory engagement, and secure data integrity across regions while collaborating with business groups to mitigate quality risks from development through distribution. The role requires extensive experience in GMP/GCP, strategic leadership, and a proven ability

Qualifications

• Bachelor’s degree and 15+ years of experience in FDA regulated pharmaceutical/medical device environments.
• Strong knowledge of current global GCP and GMP, audit techniques, and regulatory inspection procedures.
• Experience with global teams, external service providers, and Japanese business interactions.
• Proven leadership in quality systems, risk mitigation, and regulatory alignment.

Responsibilities

• Inspire and develop a QA team; deliver Global Quality strategy.
• Ensure inspection readiness across clinical sites and PV operations; manage CAPAs.
• Lead audits with timely corrective actions and systemic trend analysis.
• Establish standards for QA programs, risk management, and policy development.
• Oversee vendor management and management reviews; manage departmental budget.

Skills

Leadership

Quality management

Regulatory engagement

Clinical quality

Auditing

Budget management

Strategic thinking

Education

Bachelor's degree

FDA-regulated pharma/devices experience

Tools

GCP

cGMP

Job description

Otsuka America Pharmaceutical Inc. seeks an Executive Director of R&D Global Quality to lead a global QA team and ensure inspection readiness for clinical and PV operations.

You will drive the global QA strategy, oversee audits, manage regulatory engagement, and secure data integrity across regions while collaborating with business groups to mitigate quality risks from development through distribution. The role requires extensive experience in GMP/GCP, strategic leadership, and a proven ability