Remote Quality Systems Manager: eQMS & Analytics

Otsuka America Pharmaceutical Inc.; Lansing (MI); Remote; USD 110,000 - 165,000; Full time

Benefits offered by this job

Comprehensive health benefits

401(k) with match

Tuition reimbursement

Paid holidays & leave

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager, Quality Systems to oversee global eQMS initiatives and drive data-centric quality improvements across the product lifecycle.

You will partner with IT, Data & Analytics, and Quality stakeholders to translate business needs into system enhancements, dashboards, and analytics. The role emphasizes process optimization, reporting, and continuous improvement, with opportunities to leverage AI and automation to strengthen compliance and

Qualifications

• 4+ years in pharmaceutical Quality, Quality Systems, or related regulated environment.
• Experience supporting electronic Quality Management Systems (eQMS).
• Experience with TrackWise Digital or Veeva or similar eQMS platforms.
• Experience developing reports, dashboards, and data-driven monitoring.
• Experience in global or matrixed organizations.

Responsibilities

• Support implementation, maintenance, and lifecycle management of global eQMS solutions.
• Partner with stakeholders to ensure system functionality supports processes and compliance.
• Lead system implementations, upgrades, and integrations.
• Provide centralized expertise to promote reliable, scalable use of Quality Systems.
• Identify issues and coordinate solutions with business/technical teams.
• Develop metrics, KPIs, and dashboards for Quality performance and trends.
• Drive digital transformation, AI, and automation within Quality processes.
• Support training and change management for system adoption.

Skills

GxP principles

ICH guidelines

Data analytics

Quality systems

Stakeholder management

Excellent communication

Education

Bachelor's degree in Life Sciences/Engineering/Pharmacy/IS

Master's degree preferred

Tools

TrackWise Digital

Veeva

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager, Quality Systems to oversee global eQMS initiatives and drive data-centric quality improvements across the product lifecycle.

You will partner with IT, Data & Analytics, and Quality stakeholders to translate business needs into system enhancements, dashboards, and analytics. The role emphasizes process optimization, reporting, and continuous improvement, with opportunities to leverage AI and automation to strengthen compliance and