Senior Specialist, Digital and Data Quality

Role: Senior Specialist in Digital and Data Quality, focusing on GMP computerized systems within biopharma manufacturing, labs, and utilities. Objectives: Ensure compliance, data integrity, and quality oversight across GxP environments, supporting product quality and patient safety. Responsibilities: collaborate with stakeholders to assess, remediate, and validate computerized systems; review validation documentation; support regulatory audits and inspection readiness; promote continuous improvement and quality culture; develop training on computerized system validation and data integrity. Requirements: Bachelor's in Science, IT, Engineering or equivalent; minimum of 5 years' experience supporting regulated pharmaceutical manufacturing, with at least 3 years in validated IT solutions or application support; strong knowledge of FDA/EU regulations (21 CFR Part 11, 210, 211, 820) and GMP standards. Preferred: professional certifications (e.g., Six Sigma, PMP), project management, and experience leading during regulatory inspections; effective cross-functional collaboration skills. HighValue: expertise in computerized systems validation, data integrity principles, GxP compliance, manufacturing/ lab automation, validated infrastructure, and regulatory audit support. WorkSetup: hybrid, with ~10% travel.