QMS Applications & Validation Specialist

Cabaletta Bio, Inc.; Philadelphia (Philadelphia County); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Paid time off

Stock options

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

QMS administration

Regulatory knowledge

Validation support

Change control

Vendor coordination

Training & documentation

Cross-functional collaboration

Education

Associate or Bachelor degree in Life Sciences or related field

Tools

ZenQMS

Veeva Quality Vault

RIM/ELN systems

Job description

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.