Business Systems Manager-Quality

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, TrackWise, 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 Do

Quality Systems Ownership and Strategy

• Serve as the business systems owner and subject matter expert for Veeva, TrackWise, 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 objectives.
• Facilitate user acceptance testing, deployment readiness, training, change management, and post-implementation support.
• Serve as an escalation point for complex application issues and provide guidance to system users, process owners, and support teams.
• Develop or oversee training materials, work instructions, process documentation, and user support resources.

How You’ll Get There

Education

• Bachelor's degree in Information Systems, Computer Science, Engineering, Life Sciences, Quality, Business, or a related discipline required.
• Master's degree or relevant professional certification preferred.

Experience

• 7 or more years of experience supporting business systems within a regulated environment.
• 5 or more years of experience supporting Quality Management Systems, electronic Quality Management Systems, or related validated applications.
• Hands-on experience administering or supporting at least one enterprise quality system, such as Veeva, TrackWise, Maximo, or comparable Quality and compliance platforms.
• Experience leading system implementations, upgrades, integrations, migrations, vendor delivery and computerized system validation activities.
• Experience in the medical device, pharmaceutical, biotechnology, or another FDA- or ISO-regulated industry strongly preferred.

Knowledge, Skills, and Abilities

• Strong understanding of Quality processes, including CAPA, complaints, audits, change control, document control, training management, nonconformance management, supplier quality, and equipment or asset quality processes.
• Working knowledge of computerized system validation, 21 CFR Part 11, data integrity requirements, and risk-based validation methodologies, and controlled systems lifecycle practices
• Understanding of integrations among Quality platforms, ERP systems, manufacturing systems, training systems, asset management systems, and reporting tools.
• Strong project management, business analysis, problem-solving, and process improvement capabilities.
• Ability to translate business, quality, and compliance needs into clear, actionable technology requirements and solutions.
• Excellent written, verbal, facilitation, and stakeholder management skills.
• Ability to lead cross-functional initiatives, manage competing priorities, and drive adoption of new processes and technology.

Leadership Competencies

• Strategic and systems-oriented thinking.
• Customer-focused business partnership.
• Accountability and disciplined execution.
• Continuous improvement and innovation.
• Clear communication and effective change leadership.
• Commitment to quality, compliance, and data integrity.

Physical Requirements

• Ability to work in a standard office environment and use computer-based systems for extended periods.
• Occasional travel may be required based on business needs.
• This role is based onsite in Aliso Viejo, CA or Burlington, MA.