Senior Quality Documents Specialist QMS/eDMS Expert

Cabaletta Bio, Inc.; Philadelphia (Philadelphia County); Hybrid; USD 100,000 - 160,000; Full time

Benefits offered by this job

Health benefits

Stock option plans

PTO

Retirement plan

Job summary

Cabaletta Bio is seeking a Sr. Specialist, Quality Documents to administer and maintain document control and QMS documentation in a regulated biotech setting.

You will ensure accuracy, currentness, and accessibility of controlled documents, records, and quality data, partnering across functions to support operations and regulatory requirements. The role involves managing document workflows, archival, and change control activities while enhancing quality processes in a fast-paced growth

Qualifications

• 7–10 years in document control, quality assurance, or quality systems in regulated biotech/pharma industries.
• Bachelors (Life Sciences) or related field; QA/GxP familiarity preferred.
• Experience with eDMS platforms such as ZenQMS and Veeva Quality Vault.

Responsibilities

• Administer and maintain document control processes and the QMS documentation.
• Manage document workflows, change control, records, and retention policies.
• Support audits, inspections, and regulatory readiness with accurate documentation.
• Collaborate across functions to ensure compliant SOPs, forms, and records.

Skills

Document Control

Quality Systems

Change Control

Audit Support

Regulatory Knowledge

eDMS

GxP/GMP

Microsoft Office

Education

Bachelor's in Life Sciences

Quality Assurance Certification

Tools

ZenQMS

Veeva Quality Vault

SharePoint

eQMS software

Job description

Cabaletta Bio is seeking a Sr. Specialist, Quality Documents to administer and maintain document control and QMS documentation in a regulated biotech setting.

You will ensure accuracy, currentness, and accessibility of controlled documents, records, and quality data, partnering across functions to support operations and regulatory requirements. The role involves managing document workflows, archival, and change control activities while enhancing quality processes in a fast-paced growth