Director, Enterprise Risk Management

Cabaletta Bio is seeking a Director, Enterprise Risk Management to establish and lead the company's enterprise risk management (ERM) program as we advance toward BLA submission and commercial launch. Reporting to the Chief Compliance Officer, this role will build a structured, company-wide approach to identifying, assessing, mitigating, and monitoring risk across clinical, regulatory, quality, and commercial operations. A core focus of the role is quality risk management across the product lifecycle, including risk-based oversight of the company's external manufacturing network of three CDMOs, ensuring the risk management framework scales with the organization as it prepares for its first product launch. Responsibilities: Enterprise Risk Management Design, implement, and lead the enterprise risk management framework, including governance structure, risk taxonomy, risk appetite statements, and escalation pathways Facilitate periodic enterprise risk assessments with executive leadership and functional owners; maintain the corporate risk register and heat maps Partner with functional leaders (Clinical, Regulatory, Quality, CMC, Commercial, IT, Finance, Legal) to identify emerging risks, define mitigation plans, and track remediation to closure Develop and deliver risk reporting to the executive team and, as appropriate, the Board or Board committees Integrate risk management with related programs, including quality risk management (ICH Q9 principles), business continuity, third-party/vendor risk, and inspection readiness Monitor the external environment (regulatory enforcement trends, industry events, evolving guidance) and translate implications into the risk program Quality Risk Management & External Manufacturing Oversight Lead the application of quality risk management principles (ICH Q9(R1)) across the product lifecycle, including risk assessments supporting manufacturing, supply chain, and quality operations Establish and maintain a risk-based framework for oversight of the company's external manufacturing network, including three CDMOs, spanning vendor risk assessments, ongoing risk monitoring, and periodic risk reviews Partner with CMC, Quality, and Supply Chain to assess and manage risks associated with CDMO performance, including deviations, change control, capacity, technology transfer, comparability, and business continuity Integrate CDMO and third-party risk into the corporate risk register with clear ownership, mitigation plans, and escalation criteria; ensure risk considerations are reflected in quality agreements and governance forums (e.g., joint steering committees, quality business reviews) Support risk-based prioritization of vendor audits and person-in-plant or oversight activities in partnership with GxP Quality Audit Ensure risk documentation supporting external manufacturing is inspection-ready and aligned with BLA submission expectations Program Leadership Serve as a trusted advisor to the CCO and functional leadership on risk matters Contribute to inspection readiness and BLA-related activities where risk management documentation and governance are in scope Build scalable tools, templates, and processes appropriate for a clinical-stage company transitioning to commercial operations Potential to build and manage a small team as the function grows Qualifications: