Sr. Quality Applications Specialist

Lead and execute Computer System Validation (CSV) activities for Quality Information Technology systems in compliance with FDA, GxP, ISO, and global regulatory requirements. Conduct and maintain formal validation documentation, including Validation Plans, Risk Assessments, IQ, OQ, PQ protocols and reports, and supporting SOPs. Coordinate validation efforts with IT, system owners, developers, vendors, and operational users, including global stakeholders when applicable. Provide quality and compliance leadership to peers, serving as a subject matter expert on CSV best practices and regulatory expectations. Support and assess documentation and system changes through formal change control and impact assessments. Identify current and future regulatory requirements for computerized systems and recommend strategies to ensure ongoing compliance. Perform system administration and configuration for Quality IT systems (e.g., QMS, CAPA, Document Control, Training, Complaints). Monitor, track, and ...