Quality Applications Specialist

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.comand 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.

We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work®

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.

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.

Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.

And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.

For the Recruiter: