Global Quality Systems Manager (Remote)

Otsuka America Pharmaceutical Inc.; Madison (WI); Remote; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical benefits

401(k) match

Paid holidays & time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager of Quality Systems to drive global electronic quality management system initiatives. This role focuses on Inspections, CAPA, Change Control, Deviations, and Audit Management while improving data governance and analytics.

The position requires partnering with Quality, IT, and analytics teams to translate business needs into system enhancements, dashboards, and digital capabilities across the lifecycle of pharmaceutical products.

Qualifications

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

Responsibilities

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

Skills

Quality Systems

GxP

Data Analytics

Stakeholder mgmt

Education

Bachelor's degree

Master's degree preferred

Tools

TrackWise Digital

Veeva

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager of Quality Systems to drive global electronic quality management system initiatives. This role focuses on Inspections, CAPA, Change Control, Deviations, and Audit Management while improving data governance and analytics.

The position requires partnering with Quality, IT, and analytics teams to translate business needs into system enhancements, dashboards, and digital capabilities across the lifecycle of pharmaceutical products.