Director, CMC Quality Assurance

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's lead program is Alpha-1 Antitrypsin Deficiency (AATD). 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 successful candidate will have a scientific background and experience ensuring compliance with applicable regulatory requirements and other relevant GMP regulations for R&D and commercial production activities. Excellent written and oral communication skills are required, as is the desire and ability to work in a small, fast-paced, and patient-focused environment. Key Responsibilities: Acts as the key Quality Assurance CMC lead on program teams. Participates in the evaluation and selection of contract manufacturing sites, analytical testing sites, clinical storage, and distribution depots, and other service providers used to support the clinical development programs. Monitors third-party vendor performance, and oversees logistics of vendors for compliance including FIH and late phase activities. Oversees GMP and GLP compliance audits (US and international), including contract manufacturing sites, analytical testing sites, contract test laboratories, and CROs to determine compliance status and to identify compliance risks. Review process and method validation protocols and reports. Oversees the QA reviews of GMP manufacturing batch records, product release and stability testing, validation reports, pharmacology and toxicology study reports. Review and approve specifications affecting product quality. Disposition of clinical and commercial batches Provide key input towards development of corporate quality policies, systems and procedures. Review and approve change controls, deviations, investigations, CAPA, and Product Quality Complaints. Interacts with manufacturing, clinical, operations, or other functional areas as they impact quality operations and ensures cross-functional completion of issues or identified actions. Assist in updating CMC sections of regulatory and quality documents. Organize and manage QA CMC employee training programs, initiate training sessions including specific GxP training, and maintain training records. Participate in risk assessment, review and approve reports. Participate in hosting regulatory inspections. Prompt communication to management of critical and/or compliance issues. Qualifications: Bachelor's or Master's degree in a related scientific field with minimum of 8-10 years of relevant experience in the biopharmaceutical/pharmaceutical industry. At least 5 years of progressively responsible experience in Quality Assurance within the pharmaceutical industry; prior management or leadership role preferred. Previous experience with FDA inspections and interaction with FDA. Expert knowledge of GMP regulations; strong knowledge of FDA, and CHMP/EU regulations. Demonstrated record in effectively managing and implementing GMP-compliant quality systems. Experience supporting early phase clinical through commercial manufacturing, including the use of contract manufacturers. Experience in RNA therapeutics and LNP-formulated drugs is highly desirable. Builds effective interactions with a broad range of internal and external organizations, teams, and individuals. Ability to think critically and take a collaborative approach to problem-solving. Excellent verbal and written communication skills. Ability to work effectively in a regulated and fast-paced environment. Demonstrates an elevated level of professional integrity and trustworthiness with strong work ethics. Able to travel domestically and internationally. Benefits: Korro offers competitive compensation, 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.

Created: 2024-11-05