Global Quality Systems Leader

Otsuka America Pharmaceutical Inc.; Augusta (ME); Remote; USD 120,000 - 150,000; Full time

Benefits offered by this job

Comprehensive medical, dental, and 401

401(k) match

Flexible PTO

Paid holidays and leave

Tuition reimbursement

Student loan assistance

Disability insurance

Life insurance

Career development

Job summary

Otsuka America Pharmaceutical Inc. seeks a Manager, Quality Systems to drive global eQMS deployment, optimization, and data governance across the pharmaceutical lifecycle. You will partner with Quality, IT, and analytics teams to design dashboards, reporting solutions, and digital capabilities that enable compliant decisions.

You will lead system enhancements, ensure regulatory alignment, and promote continuous improvement of workflows, data quality, and user adoption in a remote, full-time role.

Qualifications

• 4+ years of experience in pharmaceutical Quality or Quality Systems.
• Experience with eQMS platforms such as TrackWise Digital or Veeva.
• Proven ability to implement and optimize quality processes and data reporting.

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.
• Help identify system-related issues and coordinate solutions with stakeholders.
• Develop, maintain, and standardize Quality dashboards and reports.
• Collaborate with IT, Data & Analytics, and business units to improve data quality and accessibility.

Skills

Quality systems

EQMS

Data analytics

Cross-functional collaboration

Regulatory compliance

Education

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

Master's degree preferred

Tools

TrackWise Digital

Veeva

Job description

Otsuka America Pharmaceutical Inc. seeks a Manager, Quality Systems to drive global eQMS deployment, optimization, and data governance across the pharmaceutical lifecycle. You will partner with Quality, IT, and analytics teams to design dashboards, reporting solutions, and digital capabilities that enable compliant decisions.

You will lead system enhancements, ensure regulatory alignment, and promote continuous improvement of workflows, data quality, and user adoption in a remote, full-time role.