Director, Enterprise Risk Management

Position Director Enterprise Risk Management

Location: Philadelphia (hybrid)

Reports to: Chief Compliance Officer

Cabaletta 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 Bios 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 this way we are not only working to improve the lives of patients but of everyone involved. #CabalettaCrew.

Were 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

About the Position:

Cabaletta Bio is seeking a Director Enterprise Risk Management to establish and lead the companys 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 companys 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:

• 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

• 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 companys 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

• 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

Required Qualifications:

• Bachelors degree in life sciences business finance or related field
• 10 years of progressive experience in the biopharmaceutical industry with significant experience in enterprise risk management and quality risk management
• Demonstrated 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 manufacturing
• Experience managing or overseeing risk across multiple CDMOs or contract manufacturing partners including vendor risk assessment and governance
• Experience supporting or operating within a pre-launch or newly commercial organization
• Strong facilitation analytical and communication skills; able to engage credibly with executives and functional experts alike
• Comfort with ambiguity and a hands-on roll-up-your-sleeves orientation appropriate for a clinical-stage company

Preferred 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 products
• Experience with cell therapy or viral vector external manufacturing networks and associated supply chain risk
• Experience presenting to boards or board committees

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 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.

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