Quality Systems Lead: eQMS & Analytics

Otsuka America Pharmaceutical Inc.

Lincoln (NE)

Remote

USD 110,000 - 180,000

Full time

3 days ago

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Benefits offered by this job

Medical benefits

401(k) match

Paid leave

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager, Quality Systems to lead the global quality systems program.

You will drive implementation, optimization, and continuous improvement of eQMS across Inspections, CAPA, Change Control, Deviations, Batch Review and Audit Management, partnering with Quality, IT, data analytics and affiliates. In this role you will translate business needs into system enhancements, develop dashboards and reporting, and advance data governance and digital

Qualifications

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

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.