Caprion Biosciences Benefits Overview

Individual contributor responsible for quality assurance in a regulated environment. Leads client audits and regulatory inspections, presents the QMS, coordinates responses and CAPA activities, and reviews quality documentation, deviations, complaints, investigations, and change controls. Supports internal audits, supplier qualification, computerized system validation, equipment lifecycle management, quality metrics, risk management, training, and continuous improvement.

Leads the development and sustainability of CellCarta’s Quality Management System and supplier quality program. Responsibilities include harmonizing procedures, analyzing quality data, coordinating document control, qualifying and auditing suppliers, managing quality agreements and corrective actions, supporting third-party vendor management, and contributing quality oversight throughout software development projects. The role also supports ISO certification audits and serves as a QMS subject matter expert.

Leads the development, harmonization, and sustainability of CellCarta’s Quality Management System and Supplier Quality Program. Responsibilities include quality data reporting, document control, supplier classification and audits, quality agreements, corrective action management, approved supplier oversight, vendor management, and quality support throughout software development lifecycles. The role also supports ISO certification audits and serves as a QMS subject matter expert while ensuring compliance with GCLP, GMP, ISO, CAP, CLIA, and global regulatory requirements.