Sr. Specialist, Quality Documents

Role: Senior Specialist, Quality Documents at Cabaletta Bio, managing document control and QMS documentation in a regulated biotech environment. Responsibilities: oversee lifecycle management of controlled documents, support QMS activities including change control and audit readiness, maintain electronic document systems, and assist with compliance and audit activities. Requirements: 7-10 years' experience in document control or quality assurance within biotech, pharma, or medical device sectors; familiarity with eDMS (e.g., Veeva, ZenQMS); knowledge of GxP, GCP, GMP, GLP; associate's or bachelor's in Life Sciences or related field preferred. HighValue: biotech/pharma quality systems, document control, GxP compliance, audit support, regulated industry. WorkSetup: hybrid Philadelphia, PA; no travel specified.