Remote Quality Systems Manager – eQMS & Analytics

Otsuka America Pharmaceutical Inc.

Honolulu (HI)

Remote

USD 120,000 - 170,000

Full time

3 days ago
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Job summary

Otsuka America Pharmaceutical Inc. seeks a Manager, Quality Systems to drive the implementation, maintenance, and optimization of global quality systems across the product lifecycle.

This role focuses on Inspections, CAPA, Change Control, Deviations, Batch Review, and Audit Management with an emphasis on data governance and meaningful reporting. You will partner with Quality process owners, IT, and analytics teams to translate needs into system enhancements, dashboards, and digital capabilities

Qualifications

  • Bachelor’s degree in life sciences, engineering, pharmacy, information systems, data/analytics or related field.
  • Master’s degree preferred.
  • Experience with electronic quality management systems (eQMS) required.
  • Experience in pharma quality/compliance environment a must.

Responsibilities

  • Support the implementation, maintenance, and lifecycle management of global eQMS solutions.
  • Collaborate with Quality, IT, and stakeholders to ensure system supports processes and compliance.
  • Lead system upgrades, integrations, and continuous improvement efforts.
  • Develop dashboards and analytics to improve quality governance and reporting.
  • Promote standardized Quality System capabilities across affiliates.

Skills

GxP & ICH guidelines
Translate business needs
Process improvement
Stakeholder management

Education

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

Tools

TrackWise Digital
Veeva

Job description

Otsuka America Pharmaceutical Inc. seeks a Manager, Quality Systems to drive the implementation, maintenance, and optimization of global quality systems across the product lifecycle.

This role focuses on Inspections, CAPA, Change Control, Deviations, Batch Review, and Audit Management with an emphasis on data governance and meaningful reporting. You will partner with Quality process owners, IT, and analytics teams to translate needs into system enhancements, dashboards, and digital capabilities

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