Remote Quality Systems Manager — eQMS & Analytics

Otsuka America Pharmaceutical Inc.

Bismarck (ND)

À distance

USD 110 000 - 160 000

Plein temps

Il y a 3 jours
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Résumé du poste

Otsuka America Pharmaceutical Inc. is seeking a Manager, Quality Systems to lead and optimize global quality systems across the product lifecycle in a remote, full-time role.

You will drive implementation, maintenance, and continuous improvement of eQMS, CAPA, Change Control, Deviations, Batch Review, and Audit Management, partnering with IT, Data & Analytics, and Quality process owners to deliver data-driven insights.

Qualifications

  • Bachelor's degree in Life Sciences, Engineering, Pharmacy, Information Systems, Data/Analytics, or a related field.
  • Master's degree preferred.
  • 4+ years in pharmaceutical Quality, Quality Systems, compliance, or related regulated environment.
  • Experience with electronic Quality Management Systems (eQMS).
  • Experience developing reports, dashboards, and data-driven performance monitoring.
  • Experience working in global or matrixed organizations.

Responsabilités

  • Support implementation, maintenance, enhancement, validation, and lifecycle management of global eQMS solutions.
  • Partner with Quality process owners and IT to ensure systems support business processes and compliance.
  • Support global system implementations, upgrades, and integrations.
  • Provide centralized expertise to promote reliable use of Quality Systems across functions.
  • Identify system-related issues and coordinate solutions with stakeholders.

Formation

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

Outils

TrackWise Digital
Veeva

Description du poste

Otsuka America Pharmaceutical Inc. is seeking a Manager, Quality Systems to lead and optimize global quality systems across the product lifecycle in a remote, full-time role.

You will drive implementation, maintenance, and continuous improvement of eQMS, CAPA, Change Control, Deviations, Batch Review, and Audit Management, partnering with IT, Data & Analytics, and Quality process owners to deliver data-driven insights.

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