Remote Global R&D Quality Executive Director

Otsuka America Pharmaceutical Inc.; Lincoln (NE); Remote; USD 180,000 - 300,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a global team responsible for ensuring inspection readiness, regulatory compliance, and data integrity across R&D and PV operations.

The role oversees GCQ, CSV, and GPV with dotted-line reporting to Asia/Europe and close collaboration with global affiliates. The leader will set strategic direction, manage audits, and partner with business groups to mitigate quality risks from development through

Qualifications

• Bachelor's degree and 15+ years in FDA regulated pharmaceutical and/or medical device industry environment.
• Strong knowledge of current global Good Clinical Practice (GCP) for designing, recording and reporting trials and regulatory inspections.
• Experience with Japanese business environment or working with a Japanese arm.
• Global pharmaceutical and medical device industry experience.
• Experience working with external service providers.
• Working knowledge of current Good Manufacturing Practice (cGMP) regulations.
• Strong leadership, project management, communication, and problem-solving skills.
• High emotional intelligence and ability to lead diverse teams.

Responsibilities

• Lead and develop a QA team and drive the Global Quality strategy.
• Ensure inspection readiness across clinical sites and PV operations.
• Oversee audits and ensure timely corrective actions and trend analysis.
• Act as primary liaison with regulatory authorities for inspections and findings.
• Maintain robust data integrity across clinical and PV data.
• Foster cross-functional partnerships to align QA with business goals.
• Develop, implement, and maintain quality policies and risk mitigation.
• Lead budget planning and departmental resource management.

Skills

Leadership

Regulatory knowledge

Quality management

GCP/GQP expertise

Audit management

Data integrity

Cross-functional collaboration

Education

Bachelor's degree

Job description

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a global team responsible for ensuring inspection readiness, regulatory compliance, and data integrity across R&D and PV operations.

The role oversees GCQ, CSV, and GPV with dotted-line reporting to Asia/Europe and close collaboration with global affiliates. The leader will set strategic direction, manage audits, and partner with business groups to mitigate quality risks from development through