Remote Quality Systems Manager – eQMS & Analytics

Otsuka America Pharmaceutical Inc.

Des Moines (IA)

Remote

USD 120,000 - 160,000

Full time

3 days ago
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Benefits offered by this job

Medical, dental, vision & prescription
401(k) match
Paid holidays
Paid leave programs
Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager, Quality Systems to lead the design, deployment, and continuous improvement of global eQMS solutions. You will partner with Quality, IT and analytics teams to enable compliant, efficient processes across the product lifecycle.

This remote, full-time role emphasizes data governance, dashboards, and AI-enabled opportunities, with responsibilities across CAPA, deviations, change control, inspections, and audit management to drive performance.

Qualifications

  • Strong understanding of GxP principles, ICH guidelines, and pharmaceutical Quality System expectations.
  • Ability to translate business requirements into system, workflow, reporting, and analytics solutions.
  • Strong process improvement and problem-solving capabilities.
  • Excellent communication and stakeholder-management skills.

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 supports business processes, compliance requirements, and evolving organizational needs.
  • Support global system implementations, upgrades, enhancements, integrations, and lifecycle management activities.
  • Provide centralized expertise to promote reliable, scalable 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 principles
Translate requirements to system/workfl
Process improvement
Stakeholder communication

Education

Bachelors in Life Sciences/Engineering/Pharmacy/IS/Data/Analytics
Master's degree preferred

Tools

TrackWise Digital
Veeva

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager, Quality Systems to lead the design, deployment, and continuous improvement of global eQMS solutions. You will partner with Quality, IT and analytics teams to enable compliant, efficient processes across the product lifecycle.

This remote, full-time role emphasizes data governance, dashboards, and AI-enabled opportunities, with responsibilities across CAPA, deviations, change control, inspections, and audit management to drive performance.

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