Vice President, Quality

Vice President, Quality

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:

• 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.
• 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.
• 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.
• 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%.

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.