Business Systems Manager-Quality

Job-:
Quality

Location:

Aliso Viejo, CA, United States;
Burlington, MA, United States

Schedule:

Full time Posted:
Job Salary Range:  - How You’ll Contribute The Business Systems Manager-Quality is responsible for the strategy, governance, implementation, enhancement, validation, and ongoing support of Quality-related business systems used across the organization. This role serves as a primary technology partner to Quality, Manufacturing, Operations, Regulatory Affairs, and other business functions, ensuring systems effectively support quality processes, regulatory compliance, data integrity, and operational excellence.

The role has primary responsibility for supporting and optimizing Veeva, Track Wise, Maximo, and other Quality systems as assigned. The Quality Systems Manager drives continuous improvement, system integration, user adoption, and technology-enabled process enhancements across the Quality organization.

What You’ll DoQuality Systems Ownership and Strategy Serve as the business systems owner and subject matter expert for Veeva, Track Wise, Maximo, and other Quality systems as assigned.

Develop and maintain application roadmaps that align system capabilities with business priorities, compliance requirements, enterprise architecture, and organizational growth.

Own or coordinate system configuration, administration, maintenance, upgrades, integrations, and lifecycle activities for assigned applications.

Partner with Quality stakeholders to define business requirements and implement enhancements that improve compliance, efficiency, data visibility, and user experience.

Manage vendor relationships, services, licensing considerations, and support agreements associated with assigned Quality platforms.

Governance, Compliance, and Validation Establish and maintain governance processes in partnership with Quality process owners for system change control, release management, access management, issue resolution, and lifecycle documentation.

Lead or coordinate risk-based computerized system validation activities, including requirements, risk assessments, test planning and execution, traceability, and periodic reviews.

Maintain assigned systems in a validated state and support compliance with applicable regulatory and quality requirements,  including FDA requirements, ISO 13485, 21 CFR Part 11, applicable GxP expectations, and data integrity principles.

Maintain inspection- and audit-ready system documentation and support internal audits, external audits, and regulatory inspections as needed.

Monitor system performance, usage, security, access, and data integrity and coordinate timely resolution of identified issues.

Business Process Improvement and Integration Analyze Quality processes and identify opportunities for automation, standardization, simplification, and improved controls.

Lead cross-functional initiatives involving Quality systems, enterprise platforms, reporting tools, and integrated business processes.

Collaborate with technical and business teams to design, implement, and support integrations between Quality systems and ERP, manufacturing, training, asset management, and analytics platforms.

Establish and maintain appropriate data governance practices for Quality-related master data, records, interfaces, and reporting.

Develop and monitor measures of system effectiveness, adoption, service performance, and process outcomes.

Project Delivery and User Enablement Lead system implementations, upgrades, migrations, and optimization projects from requirements through stabilization.

Develop and manage project plans, milestones, risks, dependencies, budgets, resources, and stakeholder communications.

Coordinate vendors, consultants, business stakeholders, and technical resources to deliver project…