Global R&D Quality Executive Director

Otsuka Pharmaceutical Co., Ltd; Northern (KY); Hybrid; USD 250,000 - 388,000; Full time

Job summary

Otsuka Pharmaceutical Co., Ltd seeks an Executive Director of R&D Global Quality to lead a global team ensuring inspection readiness, regulatory engagement, and data integrity across GCQ, CSV, and GPV. This role partners with regions to harmonize processes and mitigate quality risks from development through distribution.

The leader will drive a robust audit program, guide CAPA effectiveness, and shape the global quality strategy in a fast-paced pharmaceutical and medical device environment.

Qualifications

• Bachelor’s degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment.
• Experience with current global GCP for trials involving human subjects.
• Strong knowledge of audit techniques and regulatory inspection procedures.

Responsibilities

• Inspection Readiness across clinical trial sites and PV operations.
• Audit Management planning, execution and follow-up for internal and external audits.
• Regulatory Authority Engagement as primary liaison for inspections.
• Ensure Data Integrity of clinical and PV data with robust quality processes.
• Lead, mentor and develop QA professionals; foster excellence and continuous improvement.
• Collaborate with stakeholders to align QA activities with regulatory requirements.
• Develop, implement and maintain policies for quality and compliance with GCP/QSR.
• Vendor Management for clinical vendors and oversight.
• Management Review system to ensure R&D oversight per QSR and company requirements.
• Budget Management for the department.

Skills

GCP knowledge

Audit techniques

Regulatory inspections

Vendor management

cGMP knowledge

Project management

Leadership

Communication

Cross-functional collaboration

Strategic thinking

Education

Bachelor's degree

Job description

Otsuka Pharmaceutical Co., Ltd seeks an Executive Director of R&D Global Quality to lead a global team ensuring inspection readiness, regulatory engagement, and data integrity across GCQ, CSV, and GPV. This role partners with regions to harmonize processes and mitigate quality risks from development through distribution.

The leader will drive a robust audit program, guide CAPA effectiveness, and shape the global quality strategy in a fast-paced pharmaceutical and medical device environment.