Quality Assurance Systems Specialist

Responsible for leading site Data Integrity (DI) maturity and computerized systems validation to ensure high-quality, compliant biopharmaceutical manufacturing. This role involves collaborating closely in person with cross-functional teams, including IT, Quality Control, Automation, and external vendors, to review, authorize, and lead validation projects for equipment and laboratory instruments. Key duties include authoring validation protocols, managing lifecycle documentation, and serving as a subject matter expert during regulatory inspections and audits. The specialist will establish DI governance, facilitate regular DI forums, and perform risk assessments, deviations, and CAPA activities. The role requires a bachelor’s degree in a scientific field, at least 5 years of industry experience with 2+ years in Quality, and proven expertise in equipment qualification, CSV, and GxP regulations. Strong communication, leadership, and risk management skills are essential for driving site DI initiatives and training operational teams.