Quality Documents Lead — QMS & Compliance

Valid8 Financial, Inc.; Philadelphia (Philadelphia County); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive benefits

PTO

Stock option plans

Job summary

Cabaletta Bio seeks a Sr. Specialist, Quality Documents to administer and maintain the company’s document control processes and QMS documentation. You will ensure controlled documents, records, and quality data are accurate, current, and accessible to support regulatory compliance.

You will work cross-functionally to manage document workflows, record retention, and change control in a regulated biotech environment during a period of rapid growth.

Qualifications

• 7–10 years in document control, QA, or quality systems in biotech/pharma/regulated industry.
• Associate's or Bachelor's in Life Sciences or related field preferred.
• Experience with eDMS (ZenQMS, Veeva Quality Vault).
• Knowledge of GxP, GCP, GMP, GLP preferred.
• Excellent organizational skills and attention to detail.

Responsibilities

• Manage lifecycle of controlled documents: creation, review, approval, issuance, revision, archival, obsolescence.
• Maintain SOPs, work instructions, forms, specifications, protocols, reports and quality records.
• Coordinate document review and archiving, ensure version control and approvals.
• Support QMS administration: deviations, CAPAs, quality records, metrics reporting.
• Assist audits and inspections; retrieve documentation and support findings remediation.

Skills

Strong written and verbal comms

Excellent organizational skills

Ability to manage multiple priorities

Team collaboration

Education

Associate's or Bachelor's in Life Sciences/QA

Tools

ZenQMS

Veeva Quality Vault

eQMS

SharePoint / MS Office

Job description

Cabaletta Bio seeks a Sr. Specialist, Quality Documents to administer and maintain the company’s document control processes and QMS documentation. You will ensure controlled documents, records, and quality data are accurate, current, and accessible to support regulatory compliance.

You will work cross-functionally to manage document workflows, record retention, and change control in a regulated biotech environment during a period of rapid growth.