Associate Director, GCP Compliance

Cabaletta Bio; Kentucky; Hybrid; USD 140,000 - 230,000; Full time

Benefits offered by this job

Stock options

Paid time off

Benefits package

Job summary

Cabaletta Bio is seeking an Associate Director, GCP Compliance to design and drive a risk-based QMS aligned with ICH GCP E6(R3). The role oversees documentation, training, vendor quality, and TMF health, enabling inspection readiness across GxP functions.

This role can be remote, hybrid, or based in Philadelphia, PA headquarters, offering a pathway to elevate quality governance and patient safety in a fast-paced biotech environment.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 5–7 years in GxP quality or compliance roles with at least 2 years in leadership or document control.
• Proven expertise in ICH GCP E6(R3) implementation and risk-based quality management.
• Experience with TMF management, CAPA systems, and inspection readiness.

Responsibilities

• Lead the design, implementation, and continuous improvement of a risk-based QMS aligned to ICH GCP E6(R3).
• Oversee controlled documentation, training, vendor quality, TMF health, and inspection readiness.
• Drive deviation management, CAPA, and trend analyses to mitigate risks.
• Coordinate cross-GxP integration and data integrity across study materials and data.

Skills

GxP quality

ICH GCP E6(R3)

TMF management

CAPA systems

Regulatory inspection readiness

Cross-functional collaboration

Education

Bachelor's degree in science

Job description

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 www.cabalettabio.com

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 www.cabalettabio.com

and connect with us on LinkedIn.

Uniquely Differentiated. Rapid. Elegant.

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. #CabalettaCrew.

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®

Description

Position Description

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.

Responsibilities

• 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 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.

Qualifications

• 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 name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.

For more information, please visit https://www.cabalettabio.com/join-our-crew

Our most important asset is our people, and we offer competitive benefits, 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.