Global R&D Quality Director - Remote Leadership

Otsuka America Pharmaceutical Inc.; Lansing (MI); 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 team ensuring inspection readiness, audit oversight, and data integrity across development through commercialization.

You will shape the strategy for GCQ, CSV and GPV, collaborate with cross-functional partners, and manage budgets while driving quality risk mitigation on a global scale.

Qualifications

• Bachelor’s degree in a regulated pharmaceutical/medical device field or equivalent.
• 15+ years of experience in FDA-regulated environments.

Responsibilities

• Inspire and develop a global QA team across R&D quality functions.
• Ensure inspection readiness of internal and external sites during health authority inspections.
• Oversee audits (internal/external) and ensure timely corrective actions and data integrity.
• Develop standards and procedures to ensure CGMP and GCP compliance and risk mitigation.

Skills

Leadership

Strategic thinking

Problem solving

Project management

Communication

Team development

Education

Bachelor’s degree

Job description

Otsuka America Pharmaceutical Inc. seeks an Executive Director of R&D Global Quality to lead a global team ensuring inspection readiness, audit oversight, and data integrity across development through commercialization.

You will shape the strategy for GCQ, CSV and GPV, collaborate with cross-functional partners, and manage budgets while driving quality risk mitigation on a global scale.