Remote Global R&D Quality Executive Director

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

Benefits offered by this job

Comprehensive medical, dental, vision,

401(k) match

Paid time off

Tuition reimbursement

Student loan assistance

Job summary

Otsuka America Pharmaceutical Inc. is seeking an experienced Executive Director of R&D Global Quality to lead a global team responsible for R&D quality across the organization, with direct US reports and dotted line accountability to Asia, Europe and North America.

The leader will ensure inspection readiness, oversee clinical trial and submission support, and drive audits and data integrity. The role provides strategic direction for GCQ, CSV and GPV, shaping end-to-end quality across development

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 human subjects.
• Experience and interaction within a Japanese company or multinational with a Japanese arm.
• Experience in global pharmaceutical/medical device industry.
• Experience with external service providers.
• Knowledge of current Good Manufacturing Practice (cGMP).
• Strong project management, leadership, problem solving, and organization skills.
• High level of emotional intelligence.
• Excellent communication and interpersonal skills.
• Ability to work with cross-functional teams.
• Strategic thinking and problem-solving abilities.
• Travel ~30%.

Responsibilities

• Inspire and develop a team of Quality professionals and deliver the Global Quality strategy.
• Ensure inspection readiness of internal and external sites and manage health authority inspections, CAPA responsiveness and effectiveness.
• Lead clinical facility and system audits across facilities, investigator sites, and vendors and ensure timely corrective actions.
• Establish standards and procedures for quality management and compliance, reporting to senior management through Management Review.
• Oversee R&D quality systems and risk management to align with company policy and strategy.

Skills

GCP knowledge

cGMP knowledge

Project management

Leadership

Communication skills

Cross-functional collaboration

Strategic thinking

Problem solving

Emotional intelligence

Global pharma industry experience

Vendor management

Education

Bachelor’s degree + 15+ years experience

Job description

Otsuka America Pharmaceutical Inc. is seeking an experienced Executive Director of R&D Global Quality to lead a global team responsible for R&D quality across the organization, with direct US reports and dotted line accountability to Asia, Europe and North America.

The leader will ensure inspection readiness, oversee clinical trial and submission support, and drive audits and data integrity. The role provides strategic direction for GCQ, CSV and GPV, shaping end-to-end quality across development