Vice President, Quality

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 Vice President of Quality is responsible for implementing, managing, and overseeing Korro Bio’s Quality Management System (QMS) and leading all corporate quality strategies, ensuring compliance with global Good Practices (GxP) regulations. This role encompasses oversight of Quality Compliance, including audits and inspection readiness, as well as managing Quality Operations, Quality Systems, and Quality Assurance Validation. You will be accountable for the day-to-day operations of the department, including goal setting, budgeting, hiring, and team development. This position demands effective leadership, training, and guidance to support Korro Bio’s Quality program, while promoting a strong Korro Bio Quality mindset across the organization. In addition, you will collaborate closely with functional leaders and work with an enterprise-wide perspective to ensure the overall success of the organization’s quality initiatives.

Key Responsibilities

Strategic Quality Management:

• Responsible for the strategic development and operational management of Korro Bio’s quality program and Quality Management System (QMS) according to global GxP regulations (GMP, GLP, GCP, GPV).
• Oversee the execution and administration of the GxP Quality Unit to ensure compliance with internal and external standards.
• Establish and maintain quality metrics to track performance and identify areas for improvement.
• Lead the development and implementation of quality strategies aligned with business objectives and regulatory requirements.
  
  

Compliance And Auditing

• Lead Quality Compliance functions, including audits, inspections, and readiness for regulatory agency visits.
• Ensure adherence to quality standards and procedures throughout the development and manufacturing process, including supply chain management.
• Conduct internal and external audits to assess compliance and identify potential risks.
• Prepare for and respond to regulatory inspections working with internal stakeholders, providing accurate and timely information to authorities.
  
  

Operational Quality Management

• Manage Quality Operations, Quality Systems, and Quality Assurance Validation teams.
• Oversee the design, execution, and validation of quality systems and processes.
• Develop and implement quality training programs in partnership with functional leadership.
  
  

Collaboration And Leadership

• Work collaboratively with Regulatory Affairs to prepare and submit regulatory submissions, including clinical trial applications and new product marketing applications.
• Partner with other functional teams (e.g., Research and Development, CMC, Clinical Operations) to ensure alignment on quality objectives and seamless execution of projects.
• Provide effective leadership, guidance, and mentorship to quality team members.
• Foster a culture of quality excellence within the organization, emphasizing continuous improvement and risk management.
  
  

Required Qualifications

• BS degree in a scientific discipline is required; a MS degree is preferred.
• Minimum of 15+ years of progressive quality experience in the Biotech/Pharmaceutical industry, with expertise across all clinical phases through to commercial. Demonstrated leadership experience in small biotech and parenteral manufacturing is strongly preferred.
• Strong knowledge of GMP with a working knowledge of either managing people or working in GCP, and GLP with the ability to apply these standards in conformance to US, EU, and ROW regulations.
• A strategic thinker who excels at overcoming obstacles, driving sound decision-making, and delivering impactful results.
• Proven experience building teams for both immediate needs and future growth, through focused hiring, coaching, and development.
• Ability to negotiate effectively and foster collaboration among individuals, leading cross-functional and cross-company quality initiatives.
• Expected travel: 20%.
  
  

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.