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Korro Bio seeks an Associate Director of Clinical Quality Assurance to provide hands-on quality oversight of clinical and nonclinical programs, ensuring studies are conducted and data generated and reported in compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Clinical Laboratory Practice (GCLP).
You will serve as the primary quality partner to Clinical Operations, Clinical Development, Regulatory Affairs, Pharmacovigilance, Data Management, and Nonclinical teams, providing practical guidance on GCP, GLP, and GCLP expectations throughout the study lifecycle. A central responsibility is planning, conducting, reporting, and following up on qualification, routine, and for-cause audits of GCP, GLP, and GCLP service providers—including CROs, nonclinical testing facilities, bioanalytical and central laboratories, and eClinical system providers. You will assess audit responses, verify CAPA effectiveness, and escalate significant or unresolved issues to Quality leadership.
You will also plan and conduct investigator site audits based on study risk, enrollment, protocol deviation trends, monitoring findings, and other quality signals; communicate observations to study teams and sites; and drive corrective actions to closure. You will manage clinical and nonclinical quality events (deviations, quality issues, investigations, CAPAs, and assessments of potential serious breaches) in partnership with study teams.
Additional responsibilities include supporting vendor selection and qualification, contributing to vendor oversight plans, negotiating and maintaining Quality Agreements with clinical and nonclinical service providers, and reviewing key study documents (protocols, informed consent forms, monitoring and data management plans, laboratory manuals, pharmacy manuals, GLP study plans and reports, clinical study reports, and Trial Master File content) from a quality perspective.
You will lead or support inspection readiness activities for Korro Bio, its CROs, and investigator sites; provide support during health authority inspections; and help prepare responses to inspection observations. You will oversee development, implementation, and maintenance of quality systems supporting clinical trial quality and GCP, GLP, and GCLP compliance, including authoring, reviewing, and improving SOPs, work instructions, and training that are phase-appropriate and scalable. You will track and trend audit findings, quality events, and vendor performance; report quality metrics and emerging risks to Quality leadership and program teams; and support the clinical and nonclinical quality components of regulatory submissions and health authority interactions.
This is an individual contributor role within a lean QA team, well suited to someone who enjoys a small-company environment and is equally comfortable leading an audit in the field and serving as the quality partner to study teams. The role calls for sound, risk-based judgment and a practical approach to protecting patient safety, participant rights, and data integrity across Korro Bio's global clinical development programs.
REQUIREMENTS:
• Bachelor's degree in Life Sciences or related scientific discipline
• Minimum 10 years of experience in the biopharmaceutical industry or clinical research, including at least 7 years in GCP or clinical Quality Assurance, with a track record of independently leading vendor and investigator site audits
• Strong experience providing sponsor-side quality oversight of outsourced clinical and nonclinical studies, including CROs, laboratories, and other service providers
• Demonstrated experience independently planning, conducting, and reporting audits of investigator sites and GCP vendors such as CROs and clinical laboratories
• Experience auditing GLP nonclinical testing facilities and/or GCLP clinical or bioanalytical laboratories
• Working knowledge of ICH E6 (including E6(R3)), 21 CFR Parts 11, 50, 54, 56, 58, and 312, EU Clinical Trials Regulation (EU) No 536/2014, and GCLP principles
• Experience managing clinical quality events, including deviations, investigations, and CAPAs
• Ability to travel up to 20% of the time, both domestic and international, including multi-day vendor and investigator site audits
