Quality Applications Specialist

Cabaletta Bio, Inc.; Philadelphia (Philadelphia County); Hybrid; USD 85,000 - 120,000; Full time

Benefits offered by this job

Competitive benefits

PTO

Stock option plans

Job summary

Cabaletta Bio in Philadelphia hybrid role seeks a Quality Applications Specialist to administer and optimize QMS applications, ensuring regulatory compliance and operational excellence across document, training, change control and CAPA modules.

You will partner with Quality, IT and vendor teams to configure workflows, validate systems, and support CSV/CSA activities in line with FDA 21 CFR Part 11 and ISO 9001 standards. Prior QMS experience is preferred.

Qualifications

• 3-7 years of experience supporting Quality Management Systems or enterprise applications.
• Experience in regulated environments preferred.
• Experience administering eQMS platforms such as ZenQMS and Veeva Quality Vault.
• Degree in Life Sciences or related field preferred.
• Knowledge of 21 CFR Part 11 electronic records and electronic signatures.

Responsibilities

• Administer and maintain eQMS software applications and related technologies.
• Configure workflows, forms, notifications, templates, reports, and user roles.
• Manage system access, permissions, and security per company policies.
• Perform routine system monitoring and health checks for optimal performance.
• Coordinate software upgrades, patches, and releases.
• Partner with stakeholders to translate business requirements into system solutions.
• Support end users with issue resolution and guidance.
• Analyze processes for automation and efficiency improvements.
• Support CSV/CSA activities and validation documentation.

Skills

Quality Management Systems

eQMS administration

Regulatory compliance

Cross-functional collaboration

GxP knowledge

Education

Associate or Bachelor degree in Life Sciences or related field

Tools

ZenQMS

Veeva Quality Vault

Job description

Position Title: Quality Applications Specialist

Location: Hybrid/Philadelphia, PA

Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn.

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew.

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.
• User Requirements Specifications (URS)
• 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.
• 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.
• 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.

• Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.

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