Director, Risk Management & Inspection Readiness

Role: Director of Risk Management & Inspection Readiness at Cabaletta Bio, focusing on facilitating BLA submission and commercialization of cell therapy products for autoimmune diseases. Responsibilities: Own and mature enterprise risk management programs, including risk assessments, mitigation tracking, and reporting; lead cross-functional inspection readiness activities supporting clinical-stage to commercial transition; develop inspection response infrastructure and collaborate with functions like CMC, Clinical, and Regulatory. Requirements: Bachelor's in life sciences, engineering, or related; 10+ years in biotech/pharma quality, compliance, or risk management, with 3+ years in leadership; experience managing FDA inspections (PAI, PLI, BIMO); strong knowledge of ICH Q9/Q10, 21 CFR Parts 210/211/600, GCP/GLP; excellent communication skills. Preferred: Cell/gene therapy experience, clinical-to-commercial transition expertise, ERM framework knowledge, risk management tools proficiency, certifications such as ASQ CQA, RAPS RAC, PMP. High-Value: Focus on biotech quality and compliance, FDA inspection readiness, enterprise risk management, cross-functional leadership, and experience within cell/gene therapy or advanced therapies. Work setup: Hybrid in Philadelphia, PA, with a focus on preparing for regulatory inspections and ensuring quality compliance for first BLA/MAA approval.