Manager, Quality Systems

Otsuka Pharmaceutical Co., Ltd.

9d•$107,718 - $161,000

About The Position

The Manager, Quality Systems supports 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. The role supports core quality processes and technology solutions, including Inspections, CAPA, Change Control, Deviations, Batch Review, and Audit Management, with a focus on enhancing system capabilities, optimizing workflows, strengthening data governance, and enabling meaningful reporting and analytics. The Manager partners with Quality process owners, IT, Data & Analytics, and cross-functional stakeholders to translate business needs into system enhancements, dashboards, reporting solutions, and emerging digital capabilities. The position supports global electronic Quality Management System (eQMS) implementations and lifecycle management, process improvement, data quality and analytics, digital transformation, user adoption, and collaboration across global and matrixed teams.

Requirements

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

Nice To Haves

Master's degree.
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.

Responsibilities

Support the implementation, maintenance, enhancement, validation, and lifecycle management of global eQMS 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 other 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 with business and technical stakeholders.
Assess Quality System workflows and identify opportunities to improve efficiency, compliance, usability, and scalability.
Support 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 complexity, improve cycle times, and enhance user experience.
Monitor system and process performance to identify recurring issues, bottlenecks, and improvement opportunities.
Partner with Quality stakeholders to define metrics, KPIs, reports, and dashboards that provide visibility into performance, compliance, risks, and trends.
Develop and maintain reports and dashboards using data generated through Quality Systems and related sources.
Support maintenance, enhancement, and standardization of Quality reporting and dashboard capabilities.
Partner with reporting, analytics, and technology teams to improve Quality data accessibility and usability.
Monitor data quality and identify opportunities to improve completeness, consistency, accuracy, and usability.
Work with process owners and system stakeholders to resolve data quality issues and strengthen upstream data capture.
Partner with IT and business stakeholders to identify and implement digital solutions that enhance Quality System capabilities and productivity.
Assess opportunities to use artificial intelligence, automation, advanced analytics, and emerging technologies in Quality processes and systems.
Support business requirements gathering and evaluation of AI-enabled solutions.
Support change management and communications for Quality System implementations, enhancements, and process changes.
Partner with Training and process owners to help users understand system functionality and related business processes.
Develop or support user guidance, communications, reference materials, and other adoption tools.
Gather user feedback to identify opportunities to improve system usability and support.
Collaborate across Global Quality, IT, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Clinical, and other functions to support integrated Quality System solutions.
Translate business needs into clear system, reporting, analytics, and data requirements.
Build 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 addressing legitimate business needs.