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Cabaletta Bio

Strategic GCP Compliance Leader - QMS & TMF

northern, KY

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About this opportunity

Cabaletta Bio lists this Strategic GCP Compliance Leader - QMS & TMF opportunity in northern, Kentucky. Review the employer’s description below for duties, qualifications and application requirements.

Job description

Cabaletta Bio is seeking an Associate Director, GCP Compliance to lead the design, implementation, and continuous improvement of a risk-based QMS aligned to ICH GCP E6(R3). You will oversee controlled documentation, training, and TMF health with inspection readiness.

The role focuses on data integrity, CAPA management, and cross-GxP integration across study materials and data, with CRO oversight and collaborative, proactive problem solving in a fast-paced biotech environment.

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