Associate Director, GCP Compliance : Tell Me

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

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.

• 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 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.

• 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

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.