Senior Specialist Digital and Data Quality

Role: Senior Specialist in Digital and Data Quality focusing on GMP computerized systems within biopharmaceutical manufacturing. Primary objectives include ensuring compliance, validation, and quality oversight of automation and IT infrastructure supporting manufacturing, laboratories, and utilities. Responsibilities encompass evaluating and remediating legacy systems, approving validation documentation, monitoring system health and compliance, supporting regulatory inspections, and driving continuous improvement initiatives. The role involves close collaboration with stakeholders such as system owners, IT, quality, and engineering, and requires providing independent quality assurance throughout system lifecycles. Qualifications: Bachelor's in Science, IT, Engineering, or related field; minimum 5 years’ experience in regulated pharmaceutical manufacturing; at least 3 years supporting validated IT solutions. Expertise needed in computerized system validation, GxP regulations (FDA/EU/ICH, 21 CFR Part 11, 210, 211, 820), and GMP environments. Preferred skills include certifications like Six Sigma or PMP, project management, and cross-functional collaboration, with experience in regulatory audits and inspection readiness. HighValue: focus on GMP computerized systems, validation, compliance, and quality assurance in pharmaceutical manufacturing, with some travel (~10%), hybrid work setup, and involvement in lifecycle management and regulatory interactions.