Senior Quality IT & Data Integrity Specialist

About the role

Merck is looking for a Senior Quality IT & Data Integrity Specialist to join its Digital and Data Quality team, supporting biologics manufacturing operations in Dunboyne. The role ensures the integrity and compliance of computerized manufacturing and laboratory systems, with a focus on Data Integrity, quality investigations and system lifecycle compliance. It works closely with Quality, Digital, Engineering and Manufacturing.

Key responsibilities

• Provide quality oversight for Data Integrity and computerized systems across manufacturing and laboratory operations
• Lead and support Data Integrity-related deviations, investigations, root cause analysis and corrective and preventive actions
• Partner with system, process and data owners so computerized systems meet business, quality and regulatory requirements
• Review and approve computerized system validation documentation, system changes, deviations and quality records
• Keep computerized systems validated and compliant throughout their lifecycle
• Oversee change control, periodic reviews, backup and recovery, incident management and business continuity
• Assess Data Integrity risks and ensure effective controls for electronic records and computerized systems
• Support new systems, validation activities and capital projects from a quality and Data Integrity perspective
• Support regulatory inspections and audits, including resolving observations on computerized systems and Data Integrity
• Monitor system compliance and performance metrics, and contribute to training and continuous improvement

Required profile

• Degree in Computer Science, Engineering, Life Sciences, Quality or a related discipline, or equivalent experience
• Strong experience in Data Integrity within a regulated pharmaceutical, biopharmaceutical or healthcare environment
• Experience leading or supporting Data Integrity investigations, deviations and quality events
• Experience supporting computerized manufacturing, laboratory or quality systems
• Experience supporting regulatory inspections, audits or inspection readiness is advantageous; biologics manufacturing experience is advantageous
• Independent ownership of competing priorities and strong cross-functional communication

Required skills

• Computerized system validation and Data Integrity principles, including electronic records and audit trails
• Good Manufacturing Practice, QMS, deviations, change control and CAPA
• Root cause analysis, risk management and quality investigations