Director, Risk Management & Inspection Readiness
About The Position
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.
Requirements
- Bachelor's degree in life sciences, engineering, or related field; advanced degree preferred
- 10+ years of progressive experience in biotech/pharmaceutical quality, compliance, or risk management, including 3+ years in a leadership role
- Direct experience preparing for and managing FDA inspections (PAI, PLI, and/or BIMO); experience hosting inspections strongly preferred
- Working knowledge of ICH Q9/Q10, 21 CFR Parts 210/211/600, GCP/GLP requirements, and quality risk management methodologies
- Demonstrated success leading cross-functional programs with executive-level reporting and governance
- Experience with CDMO/external manufacturing oversight and supplier quality risk management
- Excellent written and verbal communication skills, including executive presentation and board-level reporting
Nice To Haves
- Cell and gene therapy or advanced therapy (ATMP) experience
- Experience in a clinical-stage company transitioning to commercial (first BLA/MAA)
- Enterprise risk management experience (COSO ERM or equivalent framework)
- Experience with eQMS platforms and risk management tools
- Certifications such as ASQ CQA, RAPS RAC, or PMP
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 PLI, PAI, and BIMO inspections
- Partner with CMC, Clinical, Regulatory, Medical Affairs, and TechOps to define function-specific readiness plans, document collection strategies, and training
- Establish readiness sign-off criteria and lead final organizational readiness verification ahead of submission and anticipated inspections
- Present risk and readiness status to senior leadership, governance committees, and the Audit Committee; tailor messaging by audience from enterprise to product to function level
- Build, coach, and develop a small team as the function scales; manage consultants and contract resources as needed
- Champion a culture of risk awareness and inspection readiness as a continuous state, not a point-in-time event
- Contribute to Quality & Compliance strategic planning, including workforce planning, budgeting, and systems roadmaps
Benefits
- competitive benefits
- PTO
- stock option plans
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What This Job Offers
Job Type
Full-time
Career Level
Director
