Remote Global R&D Quality Executive Leader

Otsuka America Pharmaceutical Inc.; Lincoln (NE); 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 focused on R&D Quality, with direct reports in the United States and dotted-line leadership across Asia, Europe, and North America.

This leader will ensure inspection readiness, oversee clinical trial and submission support, and drive continuous improvement of quality systems from development through commercialization.

Qualifications

• Extensive knowledge of global GCP and regulatory inspection procedures.
• Experience leading QA teams across global sites and vendors.
• Familiarity with cGMP and quality systems across development through commercialization.
• Strong communication and stakeholder management skills.

Responsibilities

• Inspire and develop a QA team and align with GQ strategy.
• Ensure inspection readiness across clinical and PV operations.
• Oversee audits and lead CAPA programs with timeliness and effectiveness.
• Establish standards to ensure compliant quality management systems.
• Engage with regulatory authorities and lead inspections and responses.
• Manage budgets and lead risk assessment activities.

Skills

Leadership

GCP knowledge

Audit management

Regulatory liaison

Quality Systems

Clinical data integrity

CV/GPV oversight

Project management

Education

Bachelor’s degree

15+ years in pharma/medical device (FDA regulated)

Job description

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a global team focused on R&D Quality, with direct reports in the United States and dotted-line leadership across Asia, Europe, and North America.

This leader will ensure inspection readiness, oversee clinical trial and submission support, and drive continuous improvement of quality systems from development through commercialization.