Associate Director, Quality Control

Kincell Bio engineers cells into therapies . With manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch.  Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, TCR, TILs, Tregs and CAR-NK technologies. We offer challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance.

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Kincell is seeking a highly motivated Associate Director, Quality Assurance who will be a key contributor to a dynamic and collaborative Quality Assurance team.

The Associate Director – Quality Control Lab will provide strategic, technical, and operational leadership for analytical quality control supporting cell therapy manufacturing.  This role oversees development, validation, qualification, and routine execution of assays required for release, stability, in-process, and characterization testing of cell-based products. The Assoc. Director Quality Control must balance coaching a technical staff, prioritization and staffing for routine production support activities, implementation of technical projects, and process optimizations. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation. The position requires working cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives. The successful candidate will lead a high-performing QC analytical team, ensure regulatory and cGMP compliance, partner cross-functionally to support tech transfers and method lifecycle management, and drive continuous improvement to enable robust and phase-appropriate QC operations.

Essential Duties and Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.

• Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc.
• Provide scientific and managerial leadership for QC functions supporting clinical and commercial cell therapy programs.
• Build, mentor, and manage a team of scientists and analysts; establish strong technical capability in cell-based, molecular, analytical, microbiological, and immunological methods.
• Along with Analytical Development, develop long-term QC strategy including method lifecycle management, assay robustness, and future-state technologies.
• Partner within Quality Control and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
• Oversee daily operations of the QC Lab to ensure safe, efficient, and compliant execution of testing activities.
• Ensure availability, qualification, and maintenance of QC equipment, reference standards, critical reagents, and controlled documents.
• Own and approve investigations, deviations, CAPAs, OOS/OOT results, change controls, and method performance reviews. Ensure adequate oversight and technical excellence for investigations and complaints.
• Lead qualification, validation,