Director, CMC QA

Requirements

• Bachelor's degree in Chemistry, Biology, or Life Sciences required.
• Minimum of 10 years of cGMP-related experience in the biopharmaceutical or pharmaceutical industry, including 8+ years of direct QA experience in a cGMP environment.
• Demonstrated knowledge of Quality Systems and cGMP within an FDA-regulated environment.
• Demonstrated knowledge of Good Distribution Practices.
• Auditing experience is required.
• Demonstrated experience providing quality oversight of CMOs, including audits, batch review, and issue resolution.
• Analytically strong with practical knowledge of how to identify key performance metrics and quality indicators to set targets and identify areas for improvement.

Additional Information

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. 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.

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