Associate Director, GCP Compliance

Philadelphia, PA

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases.

The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases.

The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit

and connect with us on Linked In.

At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well‑being and continuous growth of each employee who joins the team.

In this way, we are not only working to improve the lives of patients, but of everyone involved. #Cabaletta Crew.

We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great:
Working at Cabaletta Bio Inc | Great Place to Work®

Reporting to the Senior Director, GCP Quality & Compliance, the Associate Director, GCP Compliance leads the design, implementation, and continuous improvement of a risk-based Quality Management System (QMS) aligned to ICH GCP E6(R3). This role ensures oversight of controlled documentation, training, vendor quality, TMF health, and inspection readiness. The Associate Director drives compliance across GxP functions, integrating Critical-to-Quality (CtQ) factors and proportionate, data-driven oversight.

This role can be remote, hybrid or based in our Philadelphia, PA headquarters.

• Risk-Based QMS Leadership:
  Build and maintain a risk-based QMS framework emphasizing CtQ factors, risk identification, control, communication, and continuous review in alignment with E6(R3) principles.
• Controlled Document Governance:
  Manage controlled document life cycles (SOPs, WIs, forms) ensuring alignment with regulatory expectations and consistent application across…