Remote Quality Systems Manager - eQMS & Analytics

Otsuka America Pharmaceutical Inc.; Helena (MT); À distance; USD 150 000 - 200 000; Plein temps

Résumé du poste

Otsuka America Pharmaceutical Inc. is seeking a Manager, Quality Systems to lead the implementation, optimization, and continuous improvement of global quality systems across the product lifecycle.

You will work with IT, analytics, and cross-functional teams to translate business needs into system enhancements, dashboards, and reporting capabilities. The role focuses on Inspections, CAPA, Change Control, Deviations, Batch Review, and Audit Management while strengthening data governance and

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, IS, or related field.
• 4+ years in pharmaceutical Quality, Quality Systems, or related regulated environment.
• Experience with eQMS platforms (TrackWise Digital, Veeva) and data reporting.
• Experience in global or matrixed organizations.
• Strong understanding of GxP and regulatory expectations.

Responsabilités

• Support implementation and lifecycle management of global electronic Quality Management System.
• Collaborate with stakeholders to ensure system supports processes and compliance.
• Support global system implementations, upgrades, integrations.
• Develop meaningful metrics, reports, and dashboards.
• Promote data governance and reporting analytics.

Connaissances

Quality systems

GxP

Data analytics

Stakeholder management

Change management

Formation

Bachelor's degree in Life Sciences / Engineering / Pharmacy / Information Systems

Master's degree preferred

Outils

TrackWise Digital

Veeva

Description du poste

Otsuka America Pharmaceutical Inc. is seeking a Manager, Quality Systems to lead the implementation, optimization, and continuous improvement of global quality systems across the product lifecycle.

You will work with IT, analytics, and cross-functional teams to translate business needs into system enhancements, dashboards, and reporting capabilities. The role focuses on Inspections, CAPA, Change Control, Deviations, Batch Review, and Audit Management while strengthening data governance and