Manager, Quality Systems

Otsuka Pharmaceutical Companies (U.S.)

. Support implementation, maintenance, enhancement, validation, and lifecycle management of global electronic Quality Management System solutions .

Posted 10/30/2026full-timeRemote • United StatesMid-LevelSenior💰 $107,718 - $161,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in electronic Quality Management Systems (eQMS) and compliance within regulated environments, with a strong focus on process improvement, data analytics, and stakeholder collaboration. Proficient in developing metrics, dashboards, and reports to enhance Quality performance and usability.

Highest-signal resume keywords

Electronic Quality Management Systems (eQMS)Quality Systems ComplianceData Analytics and ReportingProcess Improvement MethodologiesStakeholder Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management SystemsData AnalyticsProcess MappingMetrics DevelopmentDashboard CreationSystem ImplementationQuality Performance MonitoringRegulatory ComplianceWorkflow OptimizationAI and Automation Solutions

Soft Skills

Excellent CommunicationStakeholder AlignmentCollaborationProblem-SolvingUser Feedback Integration

Tools & Technologies

TrackWise DigitalVeevaAdvanced Analytics ToolsReporting SoftwareQuality Data Systems

Industry Keywords

GxP PrinciplesICH GuidelinesPharmaceutical Quality SystemsRegulated EnvironmentContinuous Improvement

About the role

Key responsibilities & impact

Support implementation, maintenance, enhancement, validation, and lifecycle management of global electronic Quality Management System solutions
Partner with Quality process owners, IT, and stakeholders to ensure system functionality supports business processes, compliance requirements, and organizational needs
Support global system implementations, upgrades, enhancements, integrations, and Quality technology initiatives
Provide centralized expertise and support for reliable, scalable, and consistent use of Quality Systems across global functions and affiliates
Identify system issues, opportunities, and enhancement needs and coordinate solutions
Assess workflows and identify opportunities to improve efficiency, compliance, usability, and scalability
Support harmonization and standardization of Quality System processes and workflows
Facilitate requirements gathering, process mapping, future-state design, testing, and implementation of system enhancements
Apply continuous improvement methodologies to reduce complexity, improve cycle times, and enhance user experience
Monitor system and process performance to identify recurring issues, bottlenecks, and improvement opportunities
Define metrics, KPIs, reports, and dashboards for Quality performance, compliance, risks, and trends
Develop and maintain reports and dashboards using Quality Systems and related data sources
Improve accessibility, usability, completeness, consistency, accuracy, and usability of Quality data
Resolve data quality issues and strengthen upstream data capture
Identify and implement digital solutions, including artificial intelligence, automation, advanced analytics, and emerging technologies
Support requirements gathering and evaluation of AI-enabled solutions
Support change management and communications for system implementations, enhancements, and process changes
Partner with Training and process owners to promote user understanding and adoption
Develop or support user guidance, communications, reference materials, and adoption tools
Gather user feedback to improve system usability and support
Collaborate across Global Quality, IT, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Clinical, and other business functions
Translate business needs into system, reporting, analytics, and data requirements
Build relationships across global and matrixed teams and facilitate stakeholder alignment
Support global affiliates and functional teams in adopting standardized Quality System capabilities

Requirements

What you’ll need

Bachelor's degree in Life Sciences, Engineering, Pharmacy, Information Systems, Data/Analytics, or a related field
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
Experience supporting system implementations, enhancements, upgrades, integrations, or lifecycle management activities
Experience developing, maintaining, or supporting reports, metrics, dashboards, and data-driven performance monitoring
Experience working within global or matrixed organizations and collaborating across business and technology functions
Strong understanding of GxP principles, ICH guidelines, and pharmaceutical Quality System expectations
Ability to translate business requirements into system, workflow, reporting, and analytics solutions
Strong process improvement and problem-solving capabilities
Excellent communication and stakeholder-management skills
Preferred: experience developing or supporting Quality dashboards and performance analytics
Preferred: understanding of AI, machine learning, generative AI, intelligent automation, or advanced analytics and their potential application within regulated Quality environments

Benefits

Comp & perks

Comprehensive medical, dental, vision, and prescription drug coverage
Company-provided basic life insurance
Accidental death and dismemberment insurance
Short-term and long-term disability insurance
Tuition reimbursement
Student loan assistance
Generous 401(k) match
Flexible time off
Paid holidays
Paid leave programs
Incentive opportunity