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Cambridge, Massachusetts, United States
Onsite
The Associate Director, Clinical QA will provide hands-on quality oversight of Korro Bio's clinical and nonclinical programs, ensuring that studies are conducted, and that data is generated and reported in compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Clinical Laboratory Practice (GCLP). A central part of this role is planning and conducting audits of contract research organizations (CROs), laboratories, and other service providers, as well as audits of investigator sites, both in the US and internationally. 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.
Serve as the primary quality partner to Clinical Operations, Clinical Development, Regula-tory Affairs, Pharmacovigilance, Data Management, and Nonclinical teams, providing clear, practical guidance on GCP, GLP, and GCLP expectations throughout the study lifecycle.
• Plan, conduct, report, and follow up on qualification, routine, and for-cause audits of GCP, GLP, and GCLP service providers, including CROs, nonclinical testing facilities, bio-analytical and central laboratories, and eClinical system providers, assessing the adequacy of audit responses, verifying CAPA effectiveness, and escalating significant or un-resolved issues to Quality leadership.
• Plan and conduct investigator site audits selected on the basis of 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.
• Manage clinical and nonclinical quality events, including deviations, quality issues, investigations, CAPAs, and assessments of potential serious breaches, in partnership with study teams.
• Support vendor selection and qualification, contribute to vendor oversight plans, and negotiate and maintain Quality Agreements (as needed) with clinical and nonclinical service providers.
• Review key study documents from a quality perspective, such as protocols and amendments, informed consent forms, monitoring and data management plans, laboratory manuals, pharmacy manuals, GLP study plans and reports, clinical study reports, and Tri-al Master File (TMF) content.
• Lead or support inspection readiness activities for Korro Bio, its CROs, and its investigator sites; provide support during health authority inspections and help prepare responses to inspection observations.
• Oversee the 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 can scale as programs advance.
• Track and trend audit findings, quality events, and vendor performance; report quality metrics and emerging risks to Quality leadership and program teams.
• Support the clinical and nonclinical quality components of regulatory submissions and health authority interactions.
• Bachelor's degree in Life Sciences or related scientific discipline required.
• Minimum of 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 CA-PAs.
• Ability to travel up to 20% of the time, both domestic and international, including multi-day vendor and investigator site audits.
