Quality Systems Lead – eQMS & Data Analytics
Otsuka America Pharmaceutical Inc.
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Benefits offered by this job
Job summary
Otsuka America Pharmaceutical Inc. is seeking a Manager, Quality Systems to lead global eQMS initiatives and drive continuous improvement across Quality processes.
You will partner with IT, Data & Analytics, and cross-functional teams to translate business needs into system enhancements, dashboards, and analytics. You will support CAPA, Change Control, Deviations, Audit Management, and batch-related processes while strengthening data governance and reporting capabilities.
Qualifications
- Bachelor's degree in Life Sciences, Engineering, Pharmacy, Information Systems, Data/Analytics, or related field.
- Master's degree preferred for advanced responsibilities.
- 4+ years in pharmaceutical Quality, Quality Systems, or related regulated environment.
- Experience with electronic Quality Management Systems (eQMS) such as TrackWise Digital or Veeva.
Responsibilities
- Support the implementation, maintenance, enhancement, validation, and lifecycle management of global eQMS solutions.
- Collaborate with Quality process owners, IT, and stakeholders to ensure system functionality supports processes and compliance.
- Lead global system implementations, upgrades, integrations, and other quality technology initiatives.
- Provide centralized expertise to promote reliable, scalable use of Quality Systems across functions.
- Identify system-related issues and coordinate solutions with business and technical teams.
Skills
Education
Tools
Job description
Otsuka America Pharmaceutical Inc. is seeking a Manager, Quality Systems to lead global eQMS initiatives and drive continuous improvement across Quality processes.
You will partner with IT, Data & Analytics, and cross-functional teams to translate business needs into system enhancements, dashboards, and analytics. You will support CAPA, Change Control, Deviations, Audit Management, and batch-related processes while strengthening data governance and reporting capabilities.
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