Executive Director, Global R&D Quality (Remote)

Otsuka America Pharmaceutical Inc.; Helena (MT); 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 QA/QC team spanning the US and international affiliates.

The role ensures inspection readiness, oversees clinical trial and PV data integrity, and reports to Senior Management on risk and quality improvements. The leader will drive strategic direction for GCQ, CSV and GPV, partner with global regions, and promote harmonized processes across 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) for designing, recording and reporting trials.
• Experience interacting within a Japanese company or multinational with a Japanese arm.

Responsibilities

• Inspire and develop a team of QA professionals and align QA activities with business objectives.
• Ensure inspection readiness across clinical trial sites and PV operations.
• Lead, mentor and develop the QA team to foster excellence and continuous improvement.
• Oversee audit planning, execution and CAPA closure.
• Communicate audit results and drive timely corrective actions.

Skills

Leadership

Regulatory knowledge

Quality management

Auditing

Stakeholder collaboration

Education

Bachelor’s degree

Tools

GCP knowledge

cGMP knowledge

Job description

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a global QA/QC team spanning the US and international affiliates.

The role ensures inspection readiness, oversees clinical trial and PV data integrity, and reports to Senior Management on risk and quality improvements. The leader will drive strategic direction for GCQ, CSV and GPV, partner with global regions, and promote harmonized processes across development through commercial distribution.