Remote Global Quality Systems Lead

Otsuka America Pharmaceutical Inc.; Denver (CO); Remote; USD 110,000 - 150,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager, Quality Systems to lead the global quality systems strategy and drive the optimization of eQMS platforms across the product lifecycle.

You will partner with Quality, IT, Data & Analytics, and cross-functional teams to translate business needs into system enhancements, dashboards, reporting solutions, and digital capabilities that improve data governance and decision-making.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Pharmacy, Information Systems, Data/Analytics, or a related field.
• Master’s degree preferred.
• 4+ years of experience in pharmaceutical Quality, Quality Systems, compliance, business systems, data/analytics, or a related regulated environment.
• Demonstrated experience supporting electronic Quality Management Systems and associated business processes.
• 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 effectively supports business processes, compliance requirements, and evolving organizational needs.
• Support global system implementations, upgrades, enhancements, integrations, and other Quality technology initiatives.
• Provide centralized expertise and support to promote reliable, scalable, and consistent use of Quality Systems across global functions and affiliates.
• Help identify system-related issues, opportunities, and enhancement needs and coordinate solutions with appropriate business and technical stakeholders.

Skills

GxP knowledge

Data-driven decisions

Communication skills

Quality dashboards

Education

Bachelor’s degree in Life Sciences/Engineering/Pharmacy/IS/Data Analytics

Master’s degree preferred

Tools

TrackWise Digital

Veeva

Job description

Otsuka America Pharmaceutical Inc. is seeking a Manager, Quality Systems to lead the global quality systems strategy and drive the optimization of eQMS platforms across the product lifecycle.

You will partner with Quality, IT, Data & Analytics, and cross-functional teams to translate business needs into system enhancements, dashboards, reporting solutions, and digital capabilities that improve data governance and decision-making.