Director, Risk Management & Inspection Readiness

Cabaletta Bio; Philadelphia (Philadelphia County); Hybrid; USD 190,000 - 270,000; Full time

Job summary

Cabaletta Bio is seeking a Director, Risk Management & Inspection Readiness to lead enterprise risk management and the cross-functional inspection readiness program, ensuring readiness for FDA pre‑license inspections and potential BLA submission. The role partners with the CCO and senior leadership to translate risk intelligence into actionable priorities and to support launch readiness.

You will drive risk assessment programs, govern risk dashboards, coordinate inspection planning, and oversee

Responsibilities

• Own and mature the enterprise risk management (ERM) program, including the annual risk assessment cycle, risk register maintenance, mitigation tracking, and reporting to executive leadership and the Audit Committee
• Facilitate risk assessments across functions, partnering with risk owners to define risk statements, scoring, mitigation plans, and escalation paths
• Lead quality risk management (QRM) in alignment with ICH Q9(R1), embedding risk-based decision‑making into quality systems, deviation/CAPA management, change control, and supplier oversight
• Oversee risk‑based vendor and CDMO oversight, including risk profiles and escalation frameworks for external manufacturing and testing partners
• Integrate commercial compliance risk considerations into the enterprise risk profile as the company approaches launch
• Develop risk dashboards, heat maps, and executive reporting that drive prioritization and resourcing decisions
• Lead the cross‑functional inspection readiness program in support of BLA submission, including program governance, roadmap execution, and monthly dashboard reporting in partnership with the PMO
• Plan and execute the gap assessment portfolio across GMP, GCP, GLP, and quality system domains; drive risk‑prioritized remediation to closure
• Design and lead internal and external mock inspections, including inspection logistics, front room/back room operations, SME preparation, and storyboard development
• Build inspection response infrastructure: document request workflows, escalation protocols, and real‑time response management for

Job description

RemoteCabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching 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.

RemoteCabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching 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. 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®

Department: Quality & Compliance

Reports to: Chief Compliance Officer

Location: Philadelphia, PA (hybrid)

Classification: Full-time, Exempt

Position Summary

Cabaletta Bio is seeking a Director, Risk Management & Inspection Readiness to lead two of the most critical, interdependent programs supporting our path to BLA submission and commercial launch. This role owns the enterprise risk management (ERM) program and the cross‑functional inspection readiness program, ensuring that the company identifies, prioritizes, and mitigates risks while building demonstrable readiness for FDA pre‑license and pre‑approval inspections (PLI/PAI), BIMO inspections, and global health authority engagements. The Director will serve as a strategic partner to the CCO and senior leadership, translating risk intelligence into inspection readiness priorities and translating inspection findings and gap assessments back into the enterprise risk profile. This is a high‑visibility role with regular exposure to the Leadership Team, Operating Leadership Team, and Audit Committee.

Key Responsibilities

Enterprise & Quality Risk Management

• Own and mature the enterprise risk management (ERM) program, including the annual risk assessment cycle, risk register maintenance, mitigation tracking, and reporting to executive leadership and the Audit Committee
• Facilitate risk assessments across functions, partnering with risk owners to define risk statements, scoring, mitigation plans, and escalation paths
• Lead quality risk management (QRM) in alignment with ICH Q9(R1), embedding risk-based decision‑making into quality systems, deviation/CAPA management, change control, and supplier oversight
• Oversee risk‑based vendor and CDMO oversight, including risk profiles and escalation frameworks for external manufacturing and testing partners
• Integrate commercial compliance risk considerations into the enterprise risk profile as the company approaches launch
• Develop risk dashboards, heat maps, and executive reporting that drive prioritization and resourcing decisions

Inspection Readiness

• Lead the cross‑functional inspection readiness program in support of BLA submission, including program governance, roadmap execution, and monthly dashboard reporting in partnership with the PMO
• Plan and execute the gap assessment portfolio across GMP, GCP, GLP, and quality system domains; drive risk‑prioritized remediation to closure
• Design and lead internal and external mock inspections, including inspection logistics, front room/back room operations, SME preparation, and storyboard development
• Build inspection response infrastructure: document request workflows, escalation protocols, and real‑time response management for