[Hiring] Manager, Quality Systems @Otsuka Pharmaceutical Co., Ltd.

Role Description

The Manager, Quality Systems is responsible for supporting the implementation, maintenance, optimization, and continuous improvement of global quality systems that enable compliance, operational excellence, data integrity, and effective decision-making across the pharmaceutical product lifecycle.

This role supports core quality processes and technology solutions, including:

• Inspections
• CAPA
• Change Control
• Deviations
• Batch Review
• Audit Management

Key Responsibilities include:

Quality Systems Support & Lifecycle Management

• 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.

Process Optimization & Continuous Improvement

• Assess Quality System workflows and identify opportunities to improve efficiency, compliance, usability, and scalability.
• Support the harmonization and standardization of Quality System processes and workflows across global functions and affiliates.
• Facilitate requirements gathering, process mapping, future-state design, testing, and implementation of system enhancements.
• Apply continuous improvement methodologies to reduce unnecessary complexity, improve cycle times, and enhance the user experience.
• Monitor system and process performance to identify recurring issues, bottlenecks, and opportunities for improvement.

Quality Data, Reporting & Analytics

• Partner with Quality stakeholders to define meaningful metrics, KPIs, reports, and dashboards that provide visibility into Quality performance, compliance, risks, and emerging trends.
• Develop and maintain reports and dashboards using data generated through Quality Systems and related data sources.
• Support the ongoing maintenance, enhancement, and standardization of Quality reporting and dashboard capabilities.
• Partner with reporting, analytics, and technology teams to improve accessibility and usability of Quality data.
• Monitor and assess data quality and identify opportunities to improve completeness, consistency, accuracy, and usability.
• Partner with process owners and system stakeholders to resolve data quality issues and strengthen upstream data capture.

Digital Transformation, Automation & AI

• Partner with IT and business stakeholders to identify and implement digital solutions that enhance Quality System capabilities and productivity.
• Assess opportunities to leverage artificial intelligence, automation, advanced analytics, and emerging technologies within Quality processes and systems.
• Support requirement gathering across the business and evaluation of AI-enabled solutions.

Training, Adoption & Change Management

• Support change management and communications associated with Quality System implementations, enhancements, and process changes.
• Partner with Training and process owners to ensure users understand system functionality and associated business processes.
• Develop or support user guidance, communications, reference materials, and other tools that promote effective adoption.
• Gather user feedback to identify opportunities to continually improve system usability and support.

Stakeholder & Cross-Functional Collaboration

• Collaborate with stakeholders across Global Quality, IT, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Clinical, and other business functions to support integrated Quality System solutions.
• Translate business needs into clear system, reporting, analytics, and data requirements.
• Build strong relationships across global and matrixed teams and facilitate alignment among business, Quality, data, and technology stakeholders.
• Support global affiliates and functional teams in adopting standardized Quality System capabilities while appropriately addressing legitimate business needs.

Qualifications

• Education: Bachelor's degree in Life Sciences, Engineering, Pharmacy, Information Systems, Data/Analytics, or a related field. Master's degree preferred.
• Experience: 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.
• Skills & Competencies: 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.

Requirements

• Experience developing or supporting Quality dashboards and performance analytics.
• Understanding of AI, machine learning, generative AI, intelligent automation, or advanced analytics and their potential application within regulated Quality environments.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage.
• Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• A generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.
• Other company provided benefits.