Remote Quality Systems Leader (eQMS & Analytics)

Otsuka America Pharmaceutical Inc.; Frankfort (KY); Remote; USD 130,000 - 170,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision

Tuition reimbursement

401(k) with match

Paid time off and holidays

Job summary

Otsuka America Pharmaceutical Inc. seeks a Manager of Quality Systems to drive the design, deployment, and continuous improvement of global eQMS and related quality data solutions.

You will collaborate with Quality, IT, Data & Analytics, and cross-functional partners to translate business needs into scalable system enhancements and insightful dashboards. The role emphasizes data governance, reporting, and AI-enabled digital capabilities while ensuring compliance with GxP and regulatory

Qualifications

• 4+ years of experience in pharmaceutical Quality, Quality Systems, compliance, business systems, data/analytics, or a related regulated environment.
• Experience with eQMS platforms such as TrackWise Digital, Veeva, or similar eQMS platforms.
• Experience supporting system implementations, enhancements, upgrades, integrations, or lifecycle management activities.
• Experience developing, maintaining, or supporting reports, metrics, dashboards, and data-driven performance monitoring.
• Experience working within global or matrixed organizations and collaborating across business and technology functions.

Responsibilities

• Support the implementation, maintenance, enhancement, validation, and lifecycle management of global electronic Quality Management System (eQMS) solutions.
• Partner with Quality process owners, IT, and other stakeholders to ensure system functionality effectively supports business processes, compliance requirements, and evolving organizational needs.
• Support global system implementations, upgrades, enhancements, integrations, and other Quality technology initiatives.
• Provide centralized expertise and support to promote reliable, scalable, and consistent use of Quality Systems across global functions and affiliates.
• Help identify system-related issues, opportunities, and enhancement needs and coordinate solutions with appropriate business and technical stakeholders.

Skills

GxP knowledge

Translate requirements

Problem solving

Communication

Education

Bachelor's degree in Life Sciences, Engineering, Pharmacy, Information Systems, Data/Analytics, or related field

Master's degree preferred

Tools

TrackWise Digital

Veeva

Job description

Otsuka America Pharmaceutical Inc. seeks a Manager of Quality Systems to drive the design, deployment, and continuous improvement of global eQMS and related quality data solutions.

You will collaborate with Quality, IT, Data & Analytics, and cross-functional partners to translate business needs into scalable system enhancements and insightful dashboards. The role emphasizes data governance, reporting, and AI-enabled digital capabilities while ensuring compliance with GxP and regulatory