Remote Quality Systems Manager, eQMS & Analytics

Otsuka America Pharmaceutical Inc.

Austin (TX)

Remote

USD 120,000 - 180,000

Full time

5 days ago

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Benefits offered by this job

Medical, dental, vision benefits

401(k) match

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Manager, Quality Systems to lead the implementation, optimization, and continuous improvement of global quality systems across the pharmaceutical product lifecycle.

The role emphasizes enhancing system capabilities, data governance, and meaningful reporting to enable informed decision-making. You will partner with Quality process owners, IT, and analytics teams to translate business needs into system enhancements, dashboards, and digital

Qualifications

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

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.
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.
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.
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.
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.
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.