Remote Quality Systems Leader – eQMS & Analytics

Otsuka America Pharmaceutical Inc.; Atlanta (GA); Remote; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) match

Tuition reimbursement

Job summary

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

The role focuses on Inspections, CAPA, Change Control, Deviations, Batch Review, and Audit Management while driving dashboards, reporting, and analytics. Collaborating with Quality, IT, and Data & Analytics teams, you will translate business needs into system enhancements, standardize workflows,

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Information Systems, Data/Analytics, or related.
• 4+ years of experience in pharmaceutical Quality, Quality Systems, compliance, data/analytics, or a related regulated environment.
• Experience with eQMS platforms such as TrackWise Digital, Veeva, or similar eQMS platforms.

Responsibilities

• Support the implementation, maintenance, enhancement, validation, and lifecycle management of global electronic Quality Management System (eQMS) solutions.
• Partner with Quality process owners, IT, and other stakeholders to ensure system functionality supports business processes and compliance.
• Support global system implementations, upgrades, enhancements, integrations, and other Quality technology initiatives.
• Provide centralized expertise to promote reliable, scalable use of Quality Systems across global functions and affiliates.
• Help identify system-related issues and coordinate solutions with stakeholders.

Skills

GxP knowledge

Quality systems

Cross-functional collaboration

Education

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

Master's degree

Tools

TrackWise Digital

Veeva

Job description

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

The role focuses on Inspections, CAPA, Change Control, Deviations, Batch Review, and Audit Management while driving dashboards, reporting, and analytics. Collaborating with Quality, IT, and Data & Analytics teams, you will translate business needs into system enhancements, standardize workflows,