Director, CMC QA

Korro Bio•Cambridge, MA

1d•Onsite

About The Position

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 being hands-on across all aspects of CMC quality. The role demands a strategic yet highly practical approach to quality systems, vendor oversight, and multi-regional regulatory compliance in support of Korro Bio's global clinical development programs.

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.

Nice To Haves

Proven leadership, negotiation, and conflict management skills with experience influencing across functions and organizations.
Exceptional interpersonal skills with a focus on rapport-building, active listening, and effective questioning.
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 manage multiple assignments in a fast-paced environment with changing priorities.
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.

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.
Provide quality and technical input to cross-functional project teams, and review internal and external documentation including protocols, reports, test methods, specifications, master batch records, and SOPs.
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.
Lead and manage the GMP Vendor Oversight Program, ensuring vendor performance is monitored and risk mitigation plans are implemented and executed as required.
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.
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.