Remote Global R&D Quality Executive

Otsuka America Pharmaceutical Inc.; Santa Fe (NM); Remote; USD 250,000 - 388,000; Full time

Benefits offered by this job

Comprehensive medical plan

Dental coverage

Vision coverage

Prescription drug coverage

Life insurance

AD&D insurance

Disability insurance — short/long term

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave

Job summary

Otsuka America Pharmaceutical, Inc. invites an experienced Executive Director of R&D Global Quality to lead a global team focused on quality across development and submission activities.

This role ensures inspection readiness, regulatory engagement, and robust CAPA processes while driving harmonization of QA across OAPI, OPDC, and affiliates. The leader will guide GCQ, CSV, and GPV, work with business groups worldwide, and align quality with regulatory requirements to mitigate risk from

Qualifications

• Bachelor’s degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment.
• Strong knowledge of global Good Clinical Practice (GCP) for designing, recording and reporting trials that involve human subjects; audit techniques and regulatory inspections.
• Experience engaging with Japanese entities or multi-nationals with a Japanese arm.
• Previous experience in 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 emotional intelligence and exceptional leadership and team development skills.
• 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 QA professionals and align with stakeholders on the Global Quality strategy.
• Ensure inspection readiness of internal and external sites and manage health authority inspections and CAPAs.
• Lead audits of clinical facilities, systems, investigators and vendors with timely corrective actions.
• Establish standards and procedures to ensure effective quality management and risk mitigation across the business units.

Skills

GCP knowledge

Regulatory inspections

Audit techniques

Leadership

Cross-functional leadership

Vendor management

Communication skills

Education

Bachelor’s degree

Job description

Otsuka America Pharmaceutical, Inc. invites an experienced Executive Director of R&D Global Quality to lead a global team focused on quality across development and submission activities.

This role ensures inspection readiness, regulatory engagement, and robust CAPA processes while driving harmonization of QA across OAPI, OPDC, and affiliates. The leader will guide GCQ, CSV, and GPV, work with business groups worldwide, and align quality with regulatory requirements to mitigate risk from