Associate Director, GCP Compliance

This role can be remote, hybrid or based in our Philadelphia, PA headquarters. Reporting to the Senior Director, GCP Quality & Compliance.

About the role

Cabaletta Bio 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.

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 team is focused on collective success. We nurture this through an active commitment to the well-being and continuous growth of each employee.

Responsibilities

• Risk-Based QMS Leadership: Build and maintain a risk-based Quality Management System (QMS) framework emphasizing Critical-to-Quality (CtQ) factors, risk identification, control, communication, and continuous review in alignment with ICH GCP E6(R3) principles.
• Controlled Document Governance: Manage controlled document lifecycles (SOPs, WIs, forms) ensuring alignment with regulatory expectations and consistent application across functions.
• Data Integrity & Systems Oversight: Oversee GxP-relevant computerized systems ensuring compliance with ALCOA++ principles, validated configurations, and secure audit trails.
• Training Program Ownership: Maintain role-based training curricula; ensure completion, tracking, and effectiveness; incorporate risk-based training needs and process updates.
• Change Control, Deviations & CAPAs: Lead deviation management, root cause analysis, and CAPA development; conduct trend analyses to identify systemic risks and preventive actions.
• TMF Quality & Inspection Readiness: Drive TMF oversight with risk-based QC, completeness checks, and metrics ensuring 24/7 inspection readiness; manage document governance and version control.
• Vendor & CRO Oversight: Apply proportionate oversight models; define quality agreements; monitor vendor metrics, audit outcomes, and compliance to CtQ activities.
• Cross-GxP Integration: Align clinical (GCP) and manufacturing (GMP) documentation, ensuring traceability, record integrity, and lifecycle control across study materials and data.
• Metrics & Management Review: Develop leading and lagging indicators for QMS performance; report outcomes during management reviews to support continuous improvement.
• Culture of Quality: Promote an accountability-driven, learning-oriented culture that prioritizes patient safety, data integrity, and operational transparency.

Requirements

• Bachelor’s degree in a scientific discipline.
• Minimum 5–7 years in GxP quality or compliance roles, with at least 2 years in a leadership or document control capacity.
• Proven expertise in ICH GCP E6(R3) implementation (risk-based quality management and proportionate vendor monitoring).
• Experience with TMF management, CAPA systems, and inspection readiness.
• Strong understanding of GCP/GMP interfaces and regulatory inspection expectations.
• Experience working with a CRO as a sponsor.
• Demonstrated ability to work independently and proactively in a fast-paced, evolving environment.
• Excellent communication, analytical, and cross-functional collaboration skills.
• Strong team orientation and passion for continuous self-development.
• Experience in the biotech industry or in a startup industrial setting is preferred.

Benefits

• Competitive benefits package.
• Paid time off (PTO).
• Stock option plans.