Senior Associate Director, Clinical QA

Lever, Inc.; Cambridge (MA); On-site; USD 190,000 - 220,000; Full time

Job summary

Korro Bio is seeking an Associate Director, Clinical QA to oversee quality across clinical and nonclinical programs, ensuring GCP/GLP/GCLP compliance. The role emphasizes auditing CROs, labs, and sites in the US and abroad, with practical risk-based judgment to protect patient safety and data integrity.

This individual contributor position fits a lean QA team in a small-company environment, requiring strong collaboration with study teams and readiness for audits and inspections.

Qualifications

• Experience in clinical QA, GCP/GLP/GCLP oversight
• Strong track record leading audits of CROs, labs, and sites
• Sponsor-side quality oversight of outsourced studies
• Willingness to travel up to 20% domestically and internationally

Responsibilities

• Serve as primary quality partner to Clinical Operations, Regulatory Affairs, Pharmacovigilance, Data Management, and Nonclinical teams
• Plan, conduct, report, and follow up audits of GCP/GLP/GCLP service providers and sites
• Assess audit responses, verify CAPA effectiveness, escalate issues to Quality leadership
• Lead or support inspection readiness activities and respond to health authority observations
• Develop, implement, and maintain scalable quality systems and SOPs for trial quality

Skills

GCP/QA experience

Audit leadership

Vendor oversight

Travel readiness

Education

Bachelor's degree in Life Sciences

Job description

Korro Bio is seeking an Associate Director, Clinical QA to oversee quality across clinical and nonclinical programs, ensuring GCP/GLP/GCLP compliance. The role emphasizes auditing CROs, labs, and sites in the US and abroad, with practical risk-based judgment to protect patient safety and data integrity.

This individual contributor position fits a lean QA team in a small-company environment, requiring strong collaboration with study teams and readiness for audits and inspections.