Remote Global R&D Quality Executive Director

Otsuka America Pharmaceutical Inc.; Cheyenne (WY); 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. This leader will ensure inspection readiness across clinical trials and PV operations, oversee audits, and engage with regulatory authorities to support development and registration activities.

The role emphasizes strategic direction, risk management, and collaboration across regions to harmonize QA processes from development through product distribution.

Qualifications

• Bachelor’s degree and 15+ years in a FDA regulated pharmaceutical and/or medical device industry environment.
• Strong knowledge of current global Good Clinical Practice (GCP) and regulatory inspection procedures.
• Experience with external service providers and global audits.
• Willingness to travel (approximately 30%).

Responsibilities

• Inspire and develop a QA team; partner with stakeholders to deliver the GQ strategy.
• Ensure sites are inspection ready and coordinate inspections on-site or remotely.
• Oversee internal and external audits; implement corrective actions and verify effectiveness.
• Establish and maintain quality management systems and risk mitigation across R&D.
• Communicate audit findings and ensure timely, robust responses.
• Lead budgeting and resource planning for the QA function.
• Advance policy development and vendor oversight for quality compliance.

Skills

Leadership

Project management

Problem solving

Communication

Strategic thinking

Collaboration

Emotional intelligence

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. This leader will ensure inspection readiness across clinical trials and PV operations, oversee audits, and engage with regulatory authorities to support development and registration activities.

The role emphasizes strategic direction, risk management, and collaboration across regions to harmonize QA processes from development through product distribution.