Quality Applications Specialist

Cabaletta Bio, Inc.; Philadelphia (Philadelphia County); Vor Ort; USD 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Health benefits

Retirement plan

Paid time off

Stock options

Zusammenfassung

Cabaletta Bio seeks a Quality Applications Specialist to administer, configure, and validate QMS applications, ensuring regulatory compliance and operational excellence. The role partners with Quality, IT, and vendors to maintain eQMS, RIM, and ELN systems.

Responsibilities include change control, training, documentation, and supporting audits and inspections. Experience in regulated biotech preferred; strong communication is essential.

Qualifikationen

• 3-7 years of experience supporting Quality Management Systems or enterprise applications.
• Experience in regulated industries preferred and eQMS administration preferred.
• Knowledge of 21 CFR Part 11 electronic records and signatures preferred.

Aufgaben

• Administer and maintain eQMS applications and related technologies.
• Configure workflows, forms, notifications, templates, reports, and user roles.
• Coordinate software upgrades, patches, and releases.
• Support CSV/CSA validation activities and related documentation.
• Partner with stakeholders to translate requirements into system solutions.
• Serve as primary contact for QMS software vendors and cross-functional teams.

Kenntnisse

QMS administration

Regulatory knowledge

Validation support

Change control

Vendor coordination

Training & documentation

Cross-functional collaboration

Ausbildung

Associate or Bachelor degree in Life Sciences or related field

Tools

ZenQMS

Veeva Quality Vault

RIM/ELN systems

Jobbeschreibung

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 Include

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 most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

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.