Manager, Quality Systems

Remote

Full time

R13185

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, and Audit Management, with a strong focus on enhancing system capabilities, optimizing workflows, strengthening data governance, and enabling meaningful reporting and analytics.

The Manager will partner closely 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.

• 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…