Quality Applications Specialist — eQMS & Compliance

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

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.