Director, Enterprise Risk Management

Philadelphia, PACategory: Quality AssuranceType: Full-timeMin. Experience: DirectorPosition Director, Enterprise Risk Management Location: Philadelphia, (hybrid)Reports to: Chief Compliance OfficerCabaletta 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 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 WorkAbout the Position: 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.This is a highly visible, cross-functional role suited to someone who can stand up a program from the ground floor, engage executive leadership and functional heads, and translate risk insights into practical, prioritized action.Responsibilities:Enterprise Risk ManagementDesign, implement, and lead the enterprise risk management framework, including governance structure, risk taxonomy, risk appetite statements, and escalation pathwaysFacilitate periodic enterprise risk assessments with executive leadership and functional owners; maintain the corporate risk register and heat mapsPartner with functional leaders (Clinical, Regulatory, Quality, CMC, Commercial, IT, Finance, Legal) to identify emerging risks, define mitigation plans, and track remediation to closureDevelop and deliver risk reporting to the executive team and, as appropriate, the Board or Board committeesIntegrate risk management with related programs, including quality risk management (ICH Q9 principles), business continuity, third-party/vendor risk, and inspection readinessMonitor the external environment (regulatory enforcement trends, industry events, evolving guidance) and translate implications into the risk programQuality Risk Management & External Manufacturing OversightLead the application of quality risk management principles (ICH Q9(R1)) across the product lifecycle, including risk assessments supporting manufacturing, supply chain, and quality operationsEstablish 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 reviewsPartner 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 continuityIntegrate 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 AuditEnsure risk documentation supporting external manufacturing is inspection-ready and aligned with BLA submission expectationsProgram LeadershipServe as a trusted advisor to the CCO and functional leadership on risk mattersContribute to inspection readiness and BLA-related activities where risk management documentation and governance are in scopeBuild scalable tools, templates, and processes appropriate for a clinical-stage company transitioning to commercial operationsPotential to build and manage a small team as the function growsRequired Qualifications:Bachelor's degree in life sciences, business, finance, or related field10+ years of progressive experience in the biopharmaceutical industry, with significant experience in enterprise risk management and quality risk managementDemonstrated experience designing or leading an ERM program (framework development, risk assessments, risk registers, executive reporting)Hands-on experience applying quality risk management (ICH Q9) in a GxP environment, including risk assessments supporting external/contract manufacturingExperience managing or overseeing risk across multiple CDMOs or contract manufacturing partners, including vendor risk assessment and governanceExperience supporting or operating within a pre-launch or newly commercial organizationStrong facilitation, analytical, and communication skills; able to engage credibly with executives and functional experts alikeComfort with ambiguity and a hands-on, roll-up-your-sleeves orientation appropriate for a clinical-stage companyPreferred Qualifications: Advanced degree (MBA, MS) or relevant certification (e.g., CRMP, ARM, CQA)Experience in cell and gene therapy, rare disease, or other specialty/complex productsExperience with cell therapy or viral vector external manufacturing networks and associated supply chain riskExperience presenting to boards or board committeesOur 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 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.Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.#LI-HYBRID