Senior Quality Documents Specialist – GxP & Compliance

Cabaletta Bio Inc.; Philadelphia (Philadelphia County); Hybrid; USD 95,000 - 130,000; Full time

Benefits offered by this job

PTO

Stock options

Job summary

Cabaletta Bio is seeking a Sr. Specialist, Quality Documents to administer and maintain the company’s document control processes and QMS documentation. The role ensures controlled documents, records, and quality data are accurate, current, and accessible to support operations and regulatory requirements.

The specialist collaborates across functions in a regulated biotech setting. This is a hybrid role based in Philadelphia, PA, as Cabaletta continues to grow and implement new processes to

Qualifications

• 7-10 years in document control, QA, or quality systems in biotech or regulated industry.
• Associate’s or Bachelor’s degree in Life Sciences or related field preferred.
• Experience with electronic document management systems (eDMS) such as ZenQMS and Veeva Quality Vault.
• Knowledge of GxP, GCP, GMP, GLP preferred.
• Strong organizational skills and attention to detail.
• Proficiency with Microsoft Office (Word, Excel, SharePoint).
• Ability to work independently and collaboratively in a fast-paced environment.

Responsibilities

• Manage lifecycle of controlled documents (creation, review, approval, revision, archival, obsolescence).
• Maintain SOPs, work instructions, forms, specifications, protocols, and quality records.

Skills

Document control

Quality systems

GxP knowledge

Regulatory inspections

Microsoft Office

Education

Bachelor’s degree in Life Sciences

Associate’s degree in Life Sciences

Tools

ZenQMS

Veeva Quality Vault

eQMS

Job description

Cabaletta Bio is seeking a Sr. Specialist, Quality Documents to administer and maintain the company’s document control processes and QMS documentation. The role ensures controlled documents, records, and quality data are accurate, current, and accessible to support operations and regulatory requirements.

The specialist collaborates across functions in a regulated biotech setting. This is a hybrid role based in Philadelphia, PA, as Cabaletta continues to grow and implement new processes to