Remote Quality Systems Manager: eQMS & Analytics

Otsuka America Pharmaceutical Inc.; Boston (MA); Remote; USD 130,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) match

Paid holidays

Paid leave programs

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. in the United States is seeking a Manager, Quality Systems to lead and optimize global quality systems across the product lifecycle.

You will drive compliance, data integrity, and reporting while partnering with IT, Data & Analytics, and cross-functional stakeholders. The role focuses on eQMS governance, CAPA, Change Control, Deviations, Audit Management, and continuous improvement of system capabilities, with a strong emphasis on enabling actionable analytics

Qualifications

• 4+ years of experience in pharmaceutical Quality, Quality Systems, compliance, business systems, data/analytics, or a related regulated environment.
• Experience with electronic Quality Management Systems (eQMS) such as TrackWise Digital or Veeva.
• Experience supporting system implementations, enhancements, upgrades, integrations, or lifecycle management.
• Experience developing, maintaining, or supporting reports, metrics, dashboards, and data-driven performance monitoring.
• Experience in global or matrixed organizations and cross-functional collaboration.

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

Stakeholder management

Data analytics

Communication

Education

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

Master's degree preferred

Tools

TrackWise Digital

Veeva

Job description

Otsuka America Pharmaceutical Inc. in the United States is seeking a Manager, Quality Systems to lead and optimize global quality systems across the product lifecycle.

You will drive compliance, data integrity, and reporting while partnering with IT, Data & Analytics, and cross-functional stakeholders. The role focuses on eQMS governance, CAPA, Change Control, Deviations, Audit Management, and continuous improvement of system capabilities, with a strong emphasis on enabling actionable analytics