Quality Applications Specialist - eQMS & Compliance
Cabaletta Bio Inc.
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Résumé du poste
Cabaletta Bio Inc. is seeking a Quality Applications Specialist to administer and optimize the Quality Management System (QMS) applications across departments.
You will configure workflows, manage access, and support regulatory compliance, ensuring data integrity and operational excellence. In this hybrid role based in Philadelphia, you will partner with Quality, IT, Regulatory Affairs, Manufacturing, and Vendors to drive continuous improvement and validation activities aligned with FDA and EU
Qualifications
- 3–7 years supporting Quality Management Systems or enterprise apps.
- Experience administering eQMS platforms such as ZenQMS and Veeva Quality Vault.
- Associate or Bachelor degree in Life Sciences or related field preferred.
- Knowledge of GCP, GMP, GLP preferred.
- Familiarity with 21 CFR Part 11 electronic records and signatures.
Responsabilités
- Administer eQMS software and related tech; configure workflows, templates, reports, and user roles.
- Partner with stakeholders to translate requirements into system solutions and provide user support.
- Support CSV/CSA validation activities and maintain validation docs.
- Coordinate system change control, testing, and approvals.
Connaissances
Formation
Outils
Description du poste
Cabaletta Bio Inc. is seeking a Quality Applications Specialist to administer and optimize the Quality Management System (QMS) applications across departments.
You will configure workflows, manage access, and support regulatory compliance, ensuring data integrity and operational excellence. In this hybrid role based in Philadelphia, you will partner with Quality, IT, Regulatory Affairs, Manufacturing, and Vendors to drive continuous improvement and validation activities aligned with FDA and EU
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