Sr. Manager - IM CSV Quality lead

Role: Lead IM Computer System Validation (CSV) Quality function, ensuring GxP-regulated systems are validated, compliant, and use AI technology appropriately. Responsibilities include developing and implementing CSV strategy aligned with regulatory standards (EU GMP Annex 11, FDA 21 CFR Part 11), overseeing lifecycle validation, maintaining data integrity (ALCOA+), managing risk-based validation approaches, and leading continuous improvement initiatives in validation practices. The role involves managing validation activities across IM systems, ensuring lifecycle compliance, and collaborating with stakeholders across Quality, IT, Manufacturing, and Digital Teams. Qualifications: Bachelor’s in Life Sciences, Engineering, or Computer Science; 10+ years in GxP environments with extensive CSV experience; strong knowledge of Data Integrity regulations, GMP standards, and quality systems. Preferred: Master’s degree, leadership experience in global or cross-site roles, project management skills, and familiarity with digital transformation and AI applications in validation. High-value specifics include focus on GxP-regulated computerized systems, Data Integrity, risk-based validation, and digital modernization efforts. The position may be based at multiple international locations with travel as needed.