Director, Risk Management & Inspection Readiness
Cabaletta Bio
August 24, 2026
Remote friendly (Philadelphia, PA)
United States
Corporate Functions
Position: Director, Risk Management & Inspection Readiness
Key Responsibilities
- Own and mature the enterprise risk management (ERM) program: annual risk assessment cycle, risk register, mitigation tracking, and executive/Audit Committee reporting.
- Facilitate cross-functional risk assessments (risk statements, scoring, mitigation plans, escalation paths).
- Lead quality risk management (QRM) aligned to ICH Q9(R1) across deviation/CAPA, change control, and supplier oversight.
- Oversee risk-based vendor/CDMO oversight, including external manufacturing/testing partners.
- Integrate commercial compliance risk into the enterprise risk profile.
- Develop executive risk reporting (dashboards/heat maps) to drive prioritization.
- Lead cross-functional inspection readiness for BLA submission: governance, roadmap execution, monthly dashboards.
- Execute gap assessments across GMP/GCP/GLP and quality system domains; drive risk-prioritized remediation to closure.
- Design/lead internal and external mock inspections; build inspection logistics and SME preparation.
- Build inspection response infrastructure (document requests, escalation, real-time response for PLI/PAI/BIMO).
- Partner with CMC, Clinical, Regulatory, Medical Affairs, and TechOps on readiness plans, document collection, and training.
- Establish readiness sign-off criteria and lead final verification.
Qualifications
Required:
- BS in life sciences/engineering (advanced degree preferred).
- 10+ years biotech/pharma quality, compliance, or risk management; 3+ years in leadership.
- Experience preparing for/hosting FDA inspections (PAI/PLI/BIMO strongly preferred).
- Working knowledge of ICH Q9/Q10, 21 CFR 210/211/600, GCP/GLP, and quality risk methods.
- Proven success leading cross-functional programs with executive/board reporting.
- CDMO/external manufacturing oversight and supplier quality risk management.
- Excellent written/verbal communication.
Preferred:
- Cell/gene therapy or ATMP experience; clinical-stage to commercial transition.
- Enterprise risk management (e.g., COSO ERM), eQMS/risk tools.
- Certifications (ASQ CQA, RAPS RAC, PMP).
Benefits
- Competitive benefits, PTO, and stock option plans.
Application Instructions
- Visit https://www.cabalettabio.com/join-our-crew.
Key Responsibilities
- Own and mature the enterprise risk management (ERM) program: annual risk assessment cycle, risk register, mitigation tracking, and executive/Audit Committee reporting.
- Facilitate cross-functional risk assessments (risk statements, scoring, mitigation plans, escalation paths).
- Lead quality risk management (QRM) aligned to ICH Q9(R1) across deviation/CAPA, change control, and supplier oversight.
- Oversee risk-based vendor/CDMO oversight, including external manufacturing/testing partners.
- Integrate commercial compliance risk into the enterprise risk profile.
- Develop executive risk reporting (dashboards/heat maps) to drive prioritization.
- Lead cross-functional inspection readiness for BLA submission: governance, roadmap execution, monthly dashboards.
- Execute gap assessments across GMP/GCP/GLP and quality system domains; drive risk-prioritized remediation to closure.
- Design/lead internal and external mock inspections; build inspection logistics and SME preparation.
- Build inspection response infrastructure (document requests, escalation, real-time response for PLI/PAI/BIMO).
- Partner with CMC, Clinical, Regulatory, Medical Affairs, and TechOps on readiness plans, document collection, and training.
- Establish readiness sign-off criteria and lead final verification.
Qualifications
Required:
- BS in life sciences/engineering (advanced degree preferred).
- 10+ years biotech/pharma quality, compliance, or risk management; 3+ years in leadership.
- Experience preparing for/hosting FDA inspections (PAI/PLI/BIMO strongly preferred).
- Working knowledge of ICH Q9/Q10, 21 CFR 210/211/600, GCP/GLP, and quality risk methods.
- Proven success leading cross-functional programs with executive/board reporting.
- CDMO/external manufacturing oversight and supplier quality risk management.
- Excellent written/verbal communication.
Preferred:
- Cell/gene therapy or ATMP experience; clinical-stage to commercial transition.
- Enterprise risk management (e.g., COSO ERM), eQMS/risk tools.
- Certifications (ASQ CQA, RAPS RAC, PMP).
Benefits
- Competitive benefits, PTO, and stock option plans.
Application Instructions
- Visit https://www.cabalettabio.com/join-our-crew.