Digital and Data Quality (Snr Specialist)

Merck Gruppe - MSD Sharp & Dohme; Ireland; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme in Ballydine, Ireland, seeks a Senior Digital and Data Quality Specialist to join the global DDQ team. You will assess, validate, and oversee computerized systems used in GMP processes, providing data integrity guidance and ensuring inspection readiness.

This hands-on role reports to the Associate Director of DDQ for EMEA and requires strong analytical, project management, and communication skills to drive data quality improvements across manufacturing,

Qualifications

• Bachelor’s degree or equivalent in Science, IT, Engineering, or related field.
• Experience delivering validated IT solutions or providing application support in GMP environments.
• Strong knowledge of regulatory expectations and quality systems in pharma.

Responsibilities

• Act as a change driver within the global QMS framework.
• Review and approve quality-related activities and drive site inspection readiness.
• Lead initiatives for standardisation of computerized systems and data integrity.

Skills

Data integrity

GxP expertise

Quality systems

Project management

Analytical skills

Communication

Teamwork

Change management

Regulatory knowledge

Education

Bachelor’s degree in Science/IT/Engineering or equivalent

Job description

Digital and Data Quality (Snr Specialist)

Location Ballydine, Tipperary, Ireland Job Type Full time

Job Description

A wonderful opportunity has arisen for a Digital and Data Quality (Snr Specialist) to join the global Digital & Data Quality (DDQ) team in Ballydine, reporting to the Associate Director of DDQ for EMEA.

In this hands-on role, you will support manufacturing, laboratory, and logistics teams to assess, select, and validate computerized systems used in GMP processes, ensuring validation effort matches system complexity and risk. You will provide quality oversight for computerized systems used in support of GMP processes, provide expert Data Integrity (DI) guidance, and support inspection readiness.

At our company, we aspire to be the premier research-intensive pharmaceutical company. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. As a Senior Specialist Digital and Data Quality, you will play a vital role in ensuring compliance with our company's policies, procedures, and regulatory expectations.

Key Responsibilities

• Act as a change driver and strategic lead to site processes within the global Quality Management System (QMS) framework.
• Influence the organizational future through review and approval of all quality-related activities, such as policies, procedures, plans, protocols, requirements, reports, deviations, and changes, as well as contributing to site inspection readiness.
• Introduce strategic initiatives on site, driving standardisation across the GMP environment for computerized systems and data integrity, and representing DDQ in global governance meetings for data integrity, computerized system validation, master data management, and lab instrumentation / systems.
• Promote cGMP and Data Integrity awareness and support a culture of continuous improvement. Help develop and maintain training on computerized systems validation, data integrity, and internal procedures.
• Work together with the business to resolve regulatory non-conformances for cGMP computerized systems and data integrity in a way that ensures business efficiency and compliance. Drive improvements on both a local and global level, based on emerging trends, compliance gaps, and system weaknesses.
• Act as a representative for DDQ management in site-and above-site meetings as needed.

Qualifications & Experience

• Bachelor’s degree, preferably in Science, Information Technology, Engineering, or equivalent.
• At least five years of demonstrable experience delivering validated IT solutions or working in an application support role.
• Strong understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH)
• Familiarity or practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or manufacturing environment.
• Strong analytical and problem-solving skills, complemented by strong communication and teamwork skills that add great value to the team’s success.
• Timely decision‑making and the ability to manage changing priorities, with strong project management skills, a sense of urgency, and a track record of delivering quality deliverables.
• Extended experience with deviations, CAPA, change control, master data, qualification/validation, and inspection readiness in a GxP environment.

Ballydine is the primary Drug Substance commercialisation hub within the network, where new processes are scaled and transitioned to commercial manufacture. The site supports clinical and commercial API supply and the transfer of processes and technologies across internal manufacturing sites and external partners.

Additional location(s) Compensation Information

Required Skills: cGMP Regulations, Change Management, Deviation Management, Good Automated Manufacturing Practice (GAMP), Manufacturing Quality Control, Pharmaceutical Quality Assurance, Product Disposition, Quality Auditing, Quality Management Standards, Regulatory Compliance, Risk Management, Strategic Planning

Employee Status: Regular

Flexible Work Arrangements: Hybrid

Job Posting End Date: 10/30/2026

Requisition ID: R422229