Quality Applications Specialist

Cabaletta Bio needs a Quality Applications Specialist. This role will be responsible for the administration, configuration, maintenance, validation support, and continuous improvement of Quality Management System (QMS) applications. This role serves as the primary liaison between Quality, Information Technology (IT), business stakeholders, and system vendors to ensure QMS applications effectively support quality processes, regulatory compliance, and operational excellence. Responsibilities: eQMS Application Administration Administer and maintain eQMS software applications and related technologies. Configure workflows, forms, notifications, templates, reports, and user roles. Manage system access, permissions, and security in accordance with company policies. Perform routine system monitoring and health checks to ensure optimal performance. Coordinate software upgrades, patches, and releases. Business Process Support Partner with department stakeholders to understand business requirements and translate them into system solutions. Support end users with issue resolution, troubleshooting, and system guidance. Analyze business processes and identify opportunities for automation and efficiency improvements. Recommend enhancements that improve usability, compliance, and data integrity. Validation and Compliance Support computerized system validation (CSV/CSA) activities in accordance with applicable regulatory requirements. Maintain validation documentation including: User Requirements Specifications (URS) Risk Assessments Test Scripts Validation Reports Traceability Matrices Ensure systems remain compliant with: FDA 21 CFR Part 11 EU Annex 11 GxP requirements ISO 9001 ISO 13485 (if applicable) Company Quality Standards Change Management Support system change control activities. Evaluate impact assessments for proposed system changes. Coordinate testing and user acceptance activities. Ensure all modifications are properly documented and approved. Vendor and Cross-Functional Coordination Serve as the primary contact for QMS software vendors. Coordinate issue resolution and enhancement requests. Collaborate with: Quality Assurance Regulatory Affairs Manufacturing Operations IT Learning & Development Compliance teams Other Stakeholders, as applicable Training and Documentation Develop and maintain system procedures, work instructions, and user guides. Deliver end-user training and support programs. Maintain training materials and reference documentation. Support inspection and audit readiness activities. Continuous Improvement Participate in QMS transformation initiatives. Identify opportunities to improve system functionality and user experience. Support implementation of new QMS modules and technologies. Stay current on industry best practices and emerging quality technologies. Qualifications: