Associate Director, Quality Systems & Compliance

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:  

·         This position requires expertise in the management of a GMP compliant Quality Management System (QMS) for Korro, both CMC and clinical operations. This includes planning/designing the user structure and workflows, and maintenance of the electronic QMS. 

·         The position will require the development of training materials, execution of the training of internal employees, and supporting internal business partners on the use of the document control, training, supplier management, audit, incident and CAPA management, and change management modules. This includes resolution of QMS user issues with the external vendor.

·         The position will require the monitoring of the QMS, including revising key Policies and Standard Operating Procedures (SOPs) to align with Korro’s clinical growth through commercialization, and administrator for all QMS modules. A particular focus for establishing cross functional training matrix, maintenance of the matrix, developing training materials, and monitor training adherence to the matrix. This individual will be responsible for reporting of the Quality Management Review metrics for each QMS process.

·         In addition, the position will be responsible for internal QA support including, but not limited to, QA review and approval of QC documentation, Executed Batch Records (EBRs), leading incident investigations and CAPA, and facilitation change management records.

• Ensure adherence to FDA, EMA, and ICH regulations, as well as internal quality policies and procedures
• Manage all aspects of the Korro QMS including, but not limited to, QMS Policies, SOPs, Training, Incident and CAPA, Change Management, and Supplier Management.
• Establish the QMS training module and develop training matrices for all CMC teams.
• Establish training courses for new users for the electronic document management system and conduct training for all Korro users.
• Establish and Monitor Document lifecycles, initiate document change requests, and monitor active workflows and archival.
• Review and approve phase appropriate Standard Operating Procedures (SOPs) and Policies for Korro’s Quality systems and functional departments.
• Train the internal teams and supporting business partners on using the QMS modules as they are implemented.
• Monitor performance of users/workflows in the system and assist the teams to facilitate closure of QMS records.
• Establish the Audit and Supplier Management modules to archive external and internal audit reports and responses, risk assessments of external vendors, and Quality Technical Agreements.

• A minimum of 10 years in the Pharmaceutical Industry, specifically working with electronic Quality Management System platforms and QA oversight of external CMOs.
• Bachelor of Science degree or higher.
• Experience implementing and maintaining an electronic QMS system.
• Ability to author, review, and, and improve SOPs in support of Korro’s clinical growth through to commercialization.
• Demonstrated ability to multi-task and work cross functionally across all CMC teams to ensure understanding and importance of GMP systems.
• Experience with managing training and supplier management processes. 
• Experience leading investigations for incidents and CAPA management and change control facilitation is desirable.
• Experience with internal QA review and approval of Quality Control reports is desirable.

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.