Remote Executive Director, Global R&D Quality

Otsuka America Pharmaceutical Inc.; Salt Lake City (UT); Remote; USD 250,000 - 388,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) match

Paid time off

Tuition reimbursement

Student loan assistance

Disability insurance

Job summary

Otsuka America Pharmaceutical Inc. seeks an experienced Executive Director of R&D Global Quality to lead a global team focused on R&D Quality.

This role includes direct reports in the United States and dotted line reporting across Asia, Europe, and North America, ensuring inspection readiness and regulatory alignment for OAPI and affiliates. You will drive the GQ strategy, oversee GCQ, CSV and GPV, manage audits, data integrity, and risk mitigation from development through commercial

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 that involve the participation of human subjects. Managing compliance with this standard to provide assurance that the rights, safety and wellbeing of trial subjects are protected, and that clinical-trial data are credible. Current and in-depth knowledge of audit techniques and government regulatory inspection procedures
• Strong engagement with the OPCJ business will be required warranting a requirement for experience and successful interaction within a Japanese company, or a multi-national with a Japanese arm.
• Previous experience of working in the global pharmaceutical and medical device industry.
• Experience working with external service providers.
• Working knowledge of current Good Manufacturing Practice (cGMP) regulations.
• Strong project management, leadership, problem solving, and organization skills.
• High level of emotional intelligence.
• Exceptional leadership and team development skills.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively with cross-functional teams.
• Strategic thinking and problem-solving abilities.
• Travel (approximately 30%)

Responsibilities

• Inspection readiness across all clinical trial sites and PV operations.
• Oversee planning, execution, and follow-up of internal and external audits to ensure compliance with regulatory requirements.
• Regulatory authority liaison to facilitate Clinical and PV inspections and address findings.
• Data integrity through robust quality processes.
• Lead and develop QA professionals and foster a culture of excellence and continuous improvement.
• Collaborate with stakeholders across the organization to align QA activities with business objectives and regulatory requirements.

Skills

Quality leadership

Regulatory compliance

GCP knowledge

Audit management

Cross-functional collaboration

Vendor management

Strategic thinking

Communication skills

Travel planning

Education

Bachelor’s degree

FDA-regulated industry experience

Job description

Otsuka America Pharmaceutical Inc. seeks an experienced Executive Director of R&D Global Quality to lead a global team focused on R&D Quality.

This role includes direct reports in the United States and dotted line reporting across Asia, Europe, and North America, ensuring inspection readiness and regulatory alignment for OAPI and affiliates. You will drive the GQ strategy, oversee GCQ, CSV and GPV, manage audits, data integrity, and risk mitigation from development through commercial