Global Quality Systems Manager – eQMS & Analytics

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

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager, Quality Systems to lead the ongoing implementation, maintenance, and optimization of global quality systems across the product lifecycle.

You will help enable compliant, data-driven decisions by improving eQMS, CAPA, change control, deviations, and audit management. You will partner with Quality process owners, IT, and analytics teams to translate business needs into system enhancements, dashboards, and reporting.

Qualifications

• Bachelor's degree or higher in a life sciences, engineering, or related field.
• Experience with electronic Quality Management Systems (eQMS).
• Knowledge of GMP/GxP standards and regulatory expectations.

Responsibilities

• Support the implementation, maintenance, and lifecycle management of global electronic Quality Management System (eQMS) solutions.
• Collaborate with Quality process owners and IT to ensure systems support compliance and business needs.
• Lead or support system upgrades, integrations, and analytics to enable reporting.
• Develop and monitor dashboards and metrics to assess Quality performance and data quality.
• Drive continuous improvement of Quality processes and digital capabilities.

Skills

GxP knowledge

Data-driven decision making

Stakeholder management

Process improvement

Education

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

Master's degree preferred

Tools

TrackWise Digital

Veeva eQMS

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager, Quality Systems to lead the ongoing implementation, maintenance, and optimization of global quality systems across the product lifecycle.

You will help enable compliant, data-driven decisions by improving eQMS, CAPA, change control, deviations, and audit management. You will partner with Quality process owners, IT, and analytics teams to translate business needs into system enhancements, dashboards, and reporting.