Director, CMC QA

Company

Summary:

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 is based in Cambridge, Massachusetts.

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 Director, CMC QA will be responsible for providing quality oversight and direction to Korro Bio's vendors to ensure that drug substance, drug product, and finished product are manufactured, tested, released, and distributed in compliance with current Good Manufacturing Practices (cGMPs). This is an individual contributor role within a lean QA team, requiring someone who thrives in a small-company environment and is comfortable being hands-on across all aspects of CMC quality.

The role demands a strategic yet highly practical approach to quality systems, vendor oversight, and multi-regional regulatory compliance in support of Korro Bio's global clinical development programs.

Key Responsibilities:

• Ensure that manufacturing operations at Contract Manufacturing Organizations (CMOs) and partners comply with regulatory requirements and internal Korro Bio quality standards.
• Lead clinical lot disposition and batch record review, ensuring products are released in compliance with Korro Bio's procedures and applicable regional requirements, and support QP certification and governance activities at contract manufacturing partners for ex-US clinical trials.
• Oversee GMP Quality Systems activities at external partners, including deviations, investigations, CAPAs, change controls, and OOS/OOT investigations ensuring timely and compliant execution and closure.
• Plan, oversee, conduct, and document qualification and periodic cGMP audits of raw material vendors, CMOs, contract testing laboratories, contract packagers/labelers, and logistics providers/distributors. Negotiate and maintain Quality Technical Agreements (QTAs) with external partners.
• Provide quality and technical input to cross-functional project teams, and review internal and external documentation including protocols, reports, test methods, specifications, master batch records, and SOPs.
• Partner with CMC, Supply Chain, and Regulatory Affairs to assess overall product quality performance, identify product-specific quality and compliance risks, and develop risk-based mitigation plans.
• Lead and manage the GMP Vendor Oversight Program, ensuring vendor performance is monitored and risk mitigation plans are implemented and executed as required.
• Develop quality metrics, assess results in collaboration with CMC, drive corrective actions with vendor quality units, and report findings to management.
• Lead quality initiatives including regulatory inspection preparations and ongoing inspection readiness activities.
• Develop, implement, and/or enhance quality systems to ensure continued compliance with company procedures and regulatory requirements.
• Suppo…