Remote Executive Director, Global R&D Quality

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

Benefits offered by this job

Medical, dental, vision

401(k) match

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a global QA team responsible for R&D quality, clinical trials support, and regulatory readiness.

The role includes direct US reports with dotted-line oversight in Asia, Europe, and North America, ensuring end-to-end quality across development to distribution. You will drive strategic direction for GCQ, CSV, and GPV, oversee audit programs, and partner with global regions to mitigate quality risks,

Qualifications

• A Bachelor’s degree is required with 15+ years in a FDA-regulated pharmaceutical/medical device environment.
• Strong knowledge of current global GCP and cGMP regulations with audit and regulatory inspection experience.
• Experience with external service providers and global quality leadership in R&D.

Responsibilities

• Inspire and develop a world-class QA team and align with Global Quality strategy.
• Ensure inspection readiness for internal and external sites during health authority inspections.
• Lead clinical facility and system audits across sites, investigators, and vendors and ensure CAPA effectiveness.
• Establish standards and procedures for quality management and risk mitigation across business units.
• Lead vendor management and management reviews in alignment with policy and strategy.
• Develop and manage departmental budgets.
• Communicate findings and drive systemic improvements to Senior Management.

Skills

Global Quality Leadership

Regulatory Compliance

Quality Systems

Clinical Quality

Audit Management

Regulatory Engagement

Data Integrity

Budget Management

Team Leadership

Cross-functional Collaboration

GxP Knowledge

Travel 30%

Education

Bachelor’s degree

15+ years in FDA-regulated environment

Job description

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a global QA team responsible for R&D quality, clinical trials support, and regulatory readiness.

The role includes direct US reports with dotted-line oversight in Asia, Europe, and North America, ensuring end-to-end quality across development to distribution. You will drive strategic direction for GCQ, CSV, and GPV, oversee audit programs, and partner with global regions to mitigate quality risks,