Korro
Biopharmaceutical
Director,CMCQA
Neural analysis suggests this role is
optimal for Director candidates.
“Director, CMC QA at Korro. Skills: CMC QA, Vendor Oversight, cGMP Compliance. Provide quality oversight to vendors. Ensure drug substance manufacturing compliance”
Industry & Context.
Problem-solving; Risk-based solutions; Issue identification
Travel up to 15%
What They're Looking For.
Must Have
Bachelor's degree in Chemistry, Biology, or Life Sciences, Minimum of 10 years of cGMP-related experience, 8+ years of direct QA experience in a cGMP environment, Demonstrated knowledge of Quality Systems and cGMP, Demonstrated knowledge of Good Distribution Practices, Auditing experience required, Demonstrated experience providing quality oversight of CMOs
Nice to Have
Proven leadership, negotiation, and conflict management skills, Exceptional interpersonal skills, Experience in problem-solving and risk-based solutions, Excellent organizational and time management skills, High level of attention to detail, Ability to manage multiple assignments, Ability to work independently and collaboratively, Experience with multi-regional GMP regulatory frameworks, Ability to travel up to 15% of the time
What You'll Do.
Provide quality oversight to vendors
Ensure drug substance manufacturing compliance
Ensure drug product manufacturing compliance
Ensure finished product manufacturing compliance
Ensure manufacturing in compliance with cGMPs
Lead clinical lot disposition
Lead batch record review
Release products in compliance with procedures
Support QP certification activities
Oversee GMP Quality Systems activities at external partners
Manage deviations at external partners
Manage investigations at external partners
Manage CAPAs at external partners
Manage change controls at external partners
Manage OOS/OOT investigations
Plan GMP audits of vendors
Oversee GMP audits of vendors
Conduct GMP audits of vendors
Document GMP audits of vendors
Negotiate Quality Technical Agreements
Maintain Quality Technical Agreements
Provide quality input to project teams
Provide technical input to project teams
Review internal documentation
Review external documentation
Partner to assess product quality performance
Identify product-specific quality risks
Identify product-specific compliance risks
Develop risk-based mitigation plans
Lead GMP Vendor Oversight Program
Monitor vendor performance
Implement risk mitigation plans
Execute risk mitigation plans
Develop quality metrics
Assess quality metrics results
Drive corrective actions with vendors
Report quality findings to management
Lead regulatory inspection preparations
Lead ongoing inspection readiness activities
Develop quality systems
Implement quality systems
Enhance quality systems
Support review of CMC regulatory submissions
Contribute to responses to health authority questions
How You'll Work.
Team & Collaboration
Cross-functional project teams; CMC; Supply Chain; Regulatory Affairs; Vendor quality units
Communication Scope
Oral communication; Written communication
Full Job Description
## Description 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. ## Position Summary The Director, CMC QA will be responsible for providing quality oversight and direction to Korro Bio's vendors to ensure that drug substance, drug product, and finished product are manufactured, tested, released, and distributed in compliance with current Good Manufacturing Practices (cGMPs). This is an individual contributor role within a lean QA team, requiring someone who thrives in a small-company environment and is comfortable b
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