Remote Executive Director, Global R&D Quality

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

Benefits offered by this job

Comprehensive benefits

401(k) match

Paid holidays

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 across OAPI, OPDC, and affiliates.

The leader will drive data integrity, regulatory engagement, and an end-to-end quality program from development through distribution. The role requires 15+ years in FDA-regulated environments, global GMP/GCP expertise, and strong leadership with cross-functional partners across regions including Asia, Europe, and North

Qualifications

• Breadth of knowledge in GMP/GCP regulations for pharma/medical devices.
• Experience leading global QA functions with inspection readiness.

Responsibilities

• Inspire and develop a QA team and deliver GQ strategy.
• Ensure sites are inspection ready and CAPAs are effective.
• Lead clinical facility and system audits across sites and vendors.
• Develop and maintain quality management systems and risk mitigation processes.
• Oversee budget and strategic QA initiatives.

Skills

Executive leadership

Audit management

Regulatory engagement

Data integrity

Team leadership

Budget management

Strategic thinking

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 QA team and ensure inspection readiness across OAPI, OPDC, and affiliates.

The leader will drive data integrity, regulatory engagement, and an end-to-end quality program from development through distribution. The role requires 15+ years in FDA-regulated environments, global GMP/GCP expertise, and strong leadership with cross-functional partners across regions including Asia, Europe, and North