Remote Global R&D Quality Executive Director

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

Benefits offered by this job

Medical, dental, vision coverage

401(k) match and retirement benefits

Paid time off and holidays

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a worldwide QA team ensuring inspection readiness, data integrity, and regulatory compliance from development through distribution.

The role includes global audit leadership, collaboration with affiliates in Asia, Europe and North America, and strategic development of quality systems with senior management oversight.

Qualifications

• Bachelor’s degree in a pharmaceutical/medical device field.
• 15+ years in FDA-regulated pharma/medical device environments.
• Strong knowledge of current global GCP and regulatory inspection processes.
• Experience collaborating with international affiliates and stakeholders.

Responsibilities

• Inspire and develop a Quality team across R&D stakeholders worldwide.
• Ensure inspection readiness of internal and external sites during health authority reviews.
• Lead audit planning, execution, and corrective action closure with timeliness.
• Advance standards and procedures for quality management and risk mitigation.
• Oversee data integrity and compliance across clinical and pharmacovigilance functions.
• Budget management and leadership development within the QA organization.
• Collaborate with cross-functional partners to align QA with business goals.

Skills

Global quality leadership

GCP knowledge

Regulatory inspection expertise

Data integrity

Audit program management

Education

Bachelor’s degree

Job description

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a worldwide QA team ensuring inspection readiness, data integrity, and regulatory compliance from development through distribution.

The role includes global audit leadership, collaboration with affiliates in Asia, Europe and North America, and strategic development of quality systems with senior management oversight.