Position Title: Quality Applications SpecialistLocation: Hybrid/Philadelphia, PA About the Position: 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.
The Quality Applications Specialist supports systems such as Document Management, Training Management, Change Control, Deviations, CAPA, Audits, Complaints, Supplier Quality, and Electronic Quality Management Systems (eQMS) in addition to Regulatory Information Management systems (RIM) and Electronic Notebook Systems (ELN).
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.
Required Qualifications: - 3-7 years of experience supporting Quality Management Systems or enterprise applications.
- Experience working in regulated industries preferred.
- Experience administering eQMS platforms preferred, such as ZenQMS and Veeva Quality Vault.
- Associate or Bachelor degree in Life Sciences, Biotechnology, Quality Assurance, or a related field preferred.
- Knowledge of GCP, GMP, GLP preferred.
- Excellent organizational skills and attention to detail.
- Ability to manage multiple priorities and meet deadlines.
- Strong written and verbal communication skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Knowledge of 21 CFR Part 11 electronic records and electronic signatures requirements.
Preferred Qualifications: - Experience supporting FDA-regulated biotechnology or pharmaceutical operations.
- Maintains accurate and compliant documentation.
- Project management skills.
- Contributes to a culture of quality and continuous improvement.
- Supports audit and inspection readiness through effective document management.
Our name - Cabaletta - is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.
For more information, please visit https://www.cabalettabio.com/join-our-crew
Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.
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