Senior Quality IT & Data Integrity Specialist - Dunboyne

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

Job Description An exciting opportunity has arisen for a Senior Quality IT & Data Integrity Specialist to join our Digital and Data Quality team supporting our biologics manufacturing operations in Dunboyne. You will play a key role in ensuring the integrity and compliance of computerized manufacturing and laboratory systems, with a particular focus on Data Integrity, quality investigations and system lifecycle compliance. Working as part of an established team, you will partner across Quality, Digital, Engineering and Manufacturing functions to investigate and resolve data-related quality events, maintain systems in a compliant state and support the continued development of a complex biologics manufacturing environment.

Bring energy, knowledge, and innovation to carry out the following:

• 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 to ensure computerized systems meet business, quality and regulatory requirements
• Review and approve computerized system validation documentation, system changes, deviations and associated quality records
• Ensure computerized systems remain in a validated and compliant state throughout their lifecycle
• Provide quality oversight for change control, periodic reviews, backup and recovery, incident management and business continuity activities
• Assess Data Integrity risks and ensure effective controls are implemented 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 the resolution of observations relating to computerized systems and Data Integrity
• Monitor system compliance and performance metrics and communicate risks and priorities to key stakeholders
• Contribute to training and capability building in Data Integrity, computerized systems and regulatory requirements
• Drive continuous improvement across Digital and Data Quality processes and ways of working

What Skills You Will Need

• Strong experience in Data Integrity within a regulated pharmaceutical, biopharmaceutical or healthcare environment
• Experience leading or supporting Data Integrity investigations, deviations and quality events
• Good understanding of computerized systems and computerized system validation principles
• Strong working knowledge of Good Manufacturing Practice and Quality Management Systems, including deviations, change control and corrective and preventive actions
• Experience supporting computerized manufacturing, laboratory or quality systems
• Understanding of Data Integrity principles, electronic records, audit trails and associated regulatory expectations
• Experience within biologics manufacturing is advantageous
• Strong investigation, analytical and problem-solving skills
• Ability to independently manage competing priorities and take ownership of issues through to resolution
• Strong cross-functional communication and stakeholder management skills
• Experience supporting regulatory inspections, audits or inspection readiness activities is advantageous
• Degree in Computer Science, Engineering, Life Sciences, Quality or a related discipline, or equivalent relevant experience

Additional location(s) Compensation Information

Required Skills: Analytical Reasoning, Change Controls, Communication, Computer System Validation (CSV), Cross-Functional Teamwork, Data Integrity, Deviations, GMP Operations, Preventive Action, Problem Solving, Quality Investigations, Quality Management Systems (QMS), Regulatory Inspections, Risk Management, Root Cause Analysis (RCA)

Preferred Skills: Biopharmaceutical Operations

Secondary Language(s) Job Description: We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs. As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 11/29/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date.