Position Director, Enterprise Risk Management Location: Philadelphia, (hybrid)Reports to: Chief Compliance OfficerAbout 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 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
Required Qualifications: - Bachelor's 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 https://www.cabalettabio.com/join-our-crew
Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.
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