Quality Systems Manager - eQMS & Data Analytics

Otsuka America Pharmaceutical Inc.

Hartford (CT)

Remote

USD 108,000 - 161,000

Full time

2 days ago
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Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager, Quality Systems to lead the global eQMS initiatives across the product lifecycle.

The role emphasizes implementation, optimization, and continuous improvement of quality systems to enable compliance, data integrity, and informed decision making. The position collaborates with Quality process owners, IT, Data & Analytics, and other stakeholders to translate business needs into system enhancements, dashboards, and analytics capabilities,

Qualifications

  • Bachelor's degree in Life Sciences, Engineering, Pharmacy, Information Systems, Data/Analytics, or a related field.
  • Master's degree preferred.
  • 4+ years of experience in pharmaceutical Quality, Quality Systems, compliance, business systems, data/analytics, or a related regulated environment.
  • Demonstrated experience supporting electronic Quality Management Systems and associated business processes.
  • 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 principles
Ability translate requirements
Process improvement
Stakeholder management

Education

Bachelor's degree in Life Sciences, Eng, 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 global eQMS initiatives across the product lifecycle.

The role emphasizes implementation, optimization, and continuous improvement of quality systems to enable compliance, data integrity, and informed decision making. The position collaborates with Quality process owners, IT, Data & Analytics, and other stakeholders to translate business needs into system enhancements, dashboards, and analytics capabilities,

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