Senior Data Integrity & Computerized Systems Leader

3563 MSD International GmbH; Dunboyne; Hybrid; EUR 85,000 - 110,000; Full time

Job summary

Merck & Co., Inc. in Ireland is seeking a Senior Quality IT & Data Integrity Specialist to join our Digital and Data Quality team supporting biologics manufacturing in Dunboyne. You will ensure data integrity across computerized systems and lead investigations and CAPAs.

In this role you will partner with Quality, Digital, Engineering and Manufacturing to maintain validated systems, support regulatory inspections, and drive continuous improvement of data integrity and system lifecycle processes.

Qualifications

• Strong experience with Data Integrity in regulated pharma/biopharma environments.
• Experience leading Data Integrity investigations, deviations and quality events.
• Good understanding of computerized systems and validation principles.
• Strong knowledge of GMP and QMS, including deviations, change control and CAPAs.

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 CAPAs.
• Partner with system, process and data owners to ensure computerized systems meet business, quality and regulatory requirements.
• Review and approve computerized system validation documentation, system changes, deviations and quality records.
• Ensure systems remain validated and compliant throughout their lifecycle.
• Oversee change control, periodic reviews, backup/recovery, incident management and business continuity.

Skills

Data Integrity

Regulatory Compliance

Investigations & RCA

GMP Knowledge

Analytical Skills

Cross-functional Collaboration

Education

Degree in Computer Science/Engineering/Life Sciences/Quality

Tools

CSV (Computer System Validation)

QMS software

Job description

Merck & Co., Inc. in Ireland is seeking a Senior Quality IT & Data Integrity Specialist to join our Digital and Data Quality team supporting biologics manufacturing in Dunboyne. You will ensure data integrity across computerized systems and lead investigations and CAPAs.

In this role you will partner with Quality, Digital, Engineering and Manufacturing to maintain validated systems, support regulatory inspections, and drive continuous improvement of data integrity and system lifecycle processes.