Korro Bio

Director, CMC QA

60 First St, Cambridge, MA 02141 · Director

Sponsorship not specified$200k-$240kDetected 50 days ago

ComplianceNegotiationAuditingSupply ChainLogisticsGMPFDA RegulatoryLeadershipCommunicationCollaborationProblem SolvingTime ManagementRegulatory Affairs

About the role

This is an individual contributor role within a lean QA team, requiring someone who thrives in a small-company environment and is comfortable being hands-on across all aspects of CMC quality.

Responsibilities

Ensure that manufacturing operations at Contract Manufacturing Organizations (CMOs) and partners comply with regulatory requirements and internal Korro Bio quality standards.
Lead clinical lot disposition and batch record review, ensuring products are released in compliance with Korro Bio's procedures and applicable regional requirements, and support QP certification and governance activities at contract manufacturing partners for ex-US clinical trials.
Oversee GMP Quality Systems activities at external partners, including deviations, investigations, CAPAs, change controls, and OOS/OOT investigations ensuring timely and compliant execution and closure.
Plan, oversee, conduct, and document qualification and periodic cGMP audits of raw material vendors, CMOs, contract testing laboratories, contract packagers/labelers, and logistics providers/distributors.
Negotiate and maintain Quality Technical Agreements (QTAs) with external partners.
Partner with CMC, Supply Chain, and Regulatory Affairs to assess overall product quality performance, identify product-specific quality and compliance risks, and develop risk-based mitigation plans.
Develop quality metrics, assess results in collaboration with CMC, drive corrective actions with vendor quality units, and report findings to management.
Lead quality initiatives including regulatory inspection preparations and ongoing inspection readiness activities.
Develop, implement, and/or enhance quality systems to ensure continued compliance with company procedures and regulatory requirements.
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.

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.
Analytically strong with practical knowledge of how to identify key performance metrics and quality indicators to set targets and identify areas for improvement.
Lead and manage the GMP Vendor Oversight Program, ensuring vendor performance is monitored and risk mitigation plans are implemented and executed as required.

Nice to have

Proven leadership, negotiation, and conflict management skills with experience influencing across functions and organizations.
Experience in environments requiring problem-solving and risk-based solutions.
Excellent organizational and time management skills with a high level of attention to detail.
Excellent oral and written communication skills for effectively interfacing with internal and external stakeholders.
Ability to work both independently and collaboratively in a team environment.
Enjoys working in a fast-paced, small-company environment and proactively identifies issues and solutions.
Experience with multi-regional GMP regulatory frameworks across the US (FDA), EU (EMA), UK (MHRA), and/or China (NMPA).
Ability to travel up to 15% of the time, both domestic and international.

Compensation

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 acc

Benefits

We are building a company with extraordinary people with an audacious vision to create transformative genetic medicines for prevalent diseases.
Join us as we redefine what's possible in genetic medicine and work to make a lasting impact on human health.
Support the review of CMC sections of regulatory submissions, including INDs and IMPDs, and contribute to responses to health authority questions related to manufacturing and quality

Company info

We are collaborative and united by a common mission.
Our values - Rewrite the future, On the Cutting Edge, Better Together, Dynamically Different, Kindness and Integrity form the fabric of the organization.

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This listing is sourced directly from Korro Bio's careers page and normalized into a canonical job model.