Global R&D Quality Executive: Inspection Readiness

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

Benefits offered by this job

Comprehensive medical, dental, vision,

401(k) with company match

Generous time off and paid holidays

Job summary

Otsuka America Pharmaceutical Inc. seeks an Executive Director of R&D Global Quality to lead a global QA team serving GQ, CSV, and GPV across OAPI, OPDC and affiliates.

The role focuses on inspection readiness, regulatory authority engagement, data integrity and continuous improvement from development through distribution. The leader will guide global quality strategy, collaborate with business groups and regions, and drive risk mitigation to ensure compliant end-to-end quality.

Qualifications

• Experience in FDA-regulated pharma/medical device environments
• Strong knowledge of GCP for human trials and audit techniques
• Experience with regulatory inspections and cross-functional collaboration

Responsibilities

• Inspire and develop a QA team; partner with key stakeholders to deliver GQ strategy
• Ensure inspection readiness across clinical sites and PV operations; manage CAPAs
• Lead clinical facility and system audits across investigators, sites and vendors
• Establish standards and procedures to ensure effective quality management and risk mitigation
• Report QA performance to Senior Management through Management Review processes
• Develop and manage departmental budgets

Skills

Global Quality

Leadership

Regulatory Compliance

Audit Management

Clinical quality

CQM/CQMS

Communication

Education

Bachelor’s degree

Job description

Otsuka America Pharmaceutical Inc. seeks an Executive Director of R&D Global Quality to lead a global QA team serving GQ, CSV, and GPV across OAPI, OPDC and affiliates.

The role focuses on inspection readiness, regulatory authority engagement, data integrity and continuous improvement from development through distribution. The leader will guide global quality strategy, collaborate with business groups and regions, and drive risk mitigation to ensure compliant end-to-end quality.