Remote Executive Director, Global R&D Quality

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

Job summary

Otsuka America Pharmaceutical Inc. is seeking an experienced Executive Director of R&D Global Quality to lead a global team focused on R&D quality, with direct reports in the United States and dotted line across Asia, Europe and North America.

The leader will ensure inspection readiness, oversee clinical trial and submission support, and drive a comprehensive audit program and data integrity across development and distribution.

Qualifications

• Bachelor’s degree in a relevant field with 15+ years in FDA-regulated pharma/medical device environments.
• Strong knowledge of current global GCP for trials and regulatory inspection procedures.
• Experience interacting with Japanese partners or a multinational with Japanese arm is preferred.

Responsibilities

• Inspire and develop a QA team; align with Global Quality strategy.
• Ensure sites are inspection ready and respond to findings within required timeframes.
• Lead audits of facilities, investigator sites, and vendors with timely corrective actions.
• Establish standards and procedures to ensure effective quality management and regulatory compliance.
• Oversee budgeting and resource planning for the QA organization.

Skills

Leadership

Quality management

Regulatory knowledge

GCP/GQ

cGMP knowledge

Audits & CAPA

Education

Bachelor’s degree

Job description

Otsuka America Pharmaceutical Inc. is seeking an experienced Executive Director of R&D Global Quality to lead a global team focused on R&D quality, with direct reports in the United States and dotted line across Asia, Europe and North America.

The leader will ensure inspection readiness, oversee clinical trial and submission support, and drive a comprehensive audit program and data integrity across development and distribution.