Business Systems Manager-Quality
About The Position
The Business Systems Manager-Quality is responsible for strategy, governance, implementation, enhancement, validation, and ongoing support of Quality-related business systems across the organization. The role partners with Quality, Manufacturing, Operations, Regulatory Affairs, and other functions to ensure systems support quality processes, regulatory compliance, data integrity, and operational excellence. It primarily supports and optimizes Veeva, TrackWise, Maximo, and other assigned Quality systems, driving continuous improvement, system integration, user adoption, and technology-enabled process enhancements. The position owns system roadmaps and lifecycle activities, coordinates configuration and integrations, manages vendor relationships, and partners with stakeholders to define requirements and implement improvements. It establishes governance for change control, releases, access, issues, and documentation; leads or coordinates risk-based computerized system validation; and maintains systems in a validated, inspection-ready state. The role also identifies process improvement and automation opportunities, supports data governance and performance measures, and leads implementations, upgrades, migrations, and optimization projects from requirements through stabilization. It coordinates project resources and stakeholders, supports testing, deployment, training, change management, and post-implementation support, and provides guidance on complex application issues. The role is based onsite in Aliso Viejo, California or Burlington, Massachusetts. Occasional travel may be required. Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on therapies for glaucoma, corneal disorders, and retinal diseases.
Requirements
- Bachelor's degree in Information Systems, Computer Science, Engineering, Life Sciences, Quality, Business, or a related discipline.
- At least 7 years of experience supporting business systems within a regulated environment.
- At least 5 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 a comparable Quality and compliance platform.
- Experience leading system implementations, upgrades, integrations, migrations, vendor delivery, and computerized system validation activities.
- 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, 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.
- Ability to work in a standard office environment and use computer-based systems for extended periods.
Nice To Haves
- Master's degree or relevant professional certification.
- Experience in the medical device, pharmaceutical, biotechnology, or another FDA- or ISO-regulated industry.
Responsibilities
- Serve as business systems owner and subject matter expert for Veeva, TrackWise, Maximo, and other assigned Quality systems.
- Develop and maintain application roadmaps aligned with business priorities, compliance requirements, enterprise architecture, and organizational growth.
- Own or coordinate application configuration, administration, maintenance, upgrades, integrations, and lifecycle activities.
- Partner with Quality stakeholders to define requirements and implement system enhancements.
- Manage vendor relationships, services, licensing considerations, and support agreements for assigned platforms.
- Establish governance processes for system change control, release management, access management, issue resolution, and lifecycle documentation.
- Lead or coordinate risk-based computerized system validation, including requirements, risk assessments, testing, traceability, and periodic reviews.
- Maintain systems in a validated state and support applicable regulatory and quality requirements and data integrity principles.
- Maintain inspection- and audit-ready system documentation and support audits and regulatory inspections.
- Monitor system performance, usage, security, access, and data integrity, and coordinate resolution of identified issues.
- 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 business and technical teams to design, implement, and support integrations with ERP, manufacturing, training, asset management, and analytics platforms.
- Establish and maintain 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.
- Lead 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 guide system users, process owners, and support teams.
- Develop or oversee training materials, work instructions, process documentation, and user support resources.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
