Remote Global R&D Quality Executive Director

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

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401k match

Paid time off

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical, Inc. seeks an Executive Director of R&D Global Quality to lead a global quality function across development and clinical operations, ensuring inspection readiness and compliant data.

The role manages teams in the US with dotted-line reporting to Asia, Europe and North America, drives audit programs, regulatory engagement, and risk mitigation from development through commercial distribution.

Qualifications

• Bachelor’s degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment.
• Strong knowledge of current global Good Clinical Practice (GCP) and audit techniques.
• Experience interacting within a Japanese company or a multinational with a Japanese arm.
• Experience in global pharma/medical device industry and with external service providers.
• Knowledge of cGMP regulations and ability to lead strategic QA initiatives.

Responsibilities

• Inspire and develop a QA team and align with the GQ strategy.
• Ensure inspection readiness across clinical sites and PV operations.
• Oversee audits and drive corrective actions with timely documentation.
• Establish policies and procedures for quality management and regulatory compliance.
• Lead vendor management and Management Review reporting to Senior Management.

Skills

Executive leadership

Quality Assurance

Regulatory liaison

Audit management

Data integrity

Team development

Cross-functional collaboration

Strategic thinking

Education

Bachelor’s degree

Job description

Otsuka America Pharmaceutical, Inc. seeks an Executive Director of R&D Global Quality to lead a global quality function across development and clinical operations, ensuring inspection readiness and compliant data.

The role manages teams in the US with dotted-line reporting to Asia, Europe and North America, drives audit programs, regulatory engagement, and risk mitigation from development through commercial distribution.