Associate Director, Clinical Quality Assurance

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

Benefits offered by this job

Equity-based compensation

Medical benefits

401(k) retirement plan

Life insurance

Dependent care FSA

Free parking

Job summary

Korro Bio, Inc. is seeking an Associate Director, Clinical QA in Cambridge, MA to provide hands-on quality oversight for clinical and nonclinical programs, ensuring compliance with GCP, GLP, and GCLP.

The role includes audits of CROs, laboratories, and sites, plus leading quality initiatives across study teams. You will partner with Clinical Operations, Regulatory Affairs, and Data Management, traveling up to 20% domestically and internationally, to protect patient safety and data integrity

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• Minimum of 10 years in biopharmaceuticals or clinical research with at least 7 years in GCP/Clinical QA.
• Strong experience overseeing outsourced clinical/nonclinical studies (CROs, labs, service providers).
• Experience auditing investigator sites and GCP vendors such as CROs and clinical laboratories.
• Experience auditing GLP nonclinical facilities and/or GCLP labs.
• Working knowledge of ICH E6, 21 CFR 11/50/54/56/58/312, EU Clinical Trials Regulation 536/2014, and GCLP principles.

Responsibilities

• Serve as the primary quality partner to Clinical Operations, Clinical Development, Regulatory Affairs, Pharmacovigilance, Data Management, and Nonclinical teams.
• Plan, conduct, report, and follow up on audits of GCP/GLP/GCLP providers and investigator sites.
• Communicate observations and drive corrective actions to closure.
• Manage quality events, deviations, investigations, CAPAs, and assess serious breaches.
• Support vendor selection, qualification, and Quality Agreements as needed.
• Review key study documents from a quality perspective (protocols, ICFs, plans, TMF).
• Lead or support inspection readiness activities and prepare responses to inspections.
• Develop and maintain quality systems, SOPs, work instructions, and training.
• Track audit findings and quality metrics; report to Quality leadership and teams.
• Support regulatory submissions and health authority interactions.

Skills

GCP

GLP

GCLP

Audit planning

Vendor audits

Investigator site audits

Quality oversight

Regulatory inspections

Education

Bachelor's degree in Life Sciences or related field

Tools

ICH E6 (R3)

21 CFR Part 11

EU CTR No. 536/2014

GCLP principles

Job description

Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body’s natural RNA editing process to effect a precise yet transient single base edit. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability. Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs. Korro’s lead program is for Urea Cycle Disorders. Korro is based in Cambridge, Massachusetts. For more information, visit korrobio.com.

We are collaborative and united by a common mission. We are building a company with extraordinary people with an audacious vision to create transformative genetic medicines for prevalent diseases. Our values - Rewrite the future, On the Cutting Edge, Better Together, Dynamically Different, Kindness and Integrity form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Korro is a magnet for outstanding talent and a great place to work. Join us as we redefine what's possible in genetic medicine and work to make a lasting impact on human health.

Position Summary

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.

Key Responsibilities

• 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.

Required Qualifications

• 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.

$190,000 - $220,000 a year

Final salary will be determined by the level at which the role is filled and by factors such as skills, competencies, experience, education, and other job-related criteria permitted by law. This range reflects base salary only and does not include annual bonus or equity.

Korro offers competitive total rewards package, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance, a dependent care flexible spending account and a Company-funded health savings account and free parking.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.