Digital and Data Quality Senior Specialist

About the role

A senior specialist will join the global Digital & Data Quality team in Ballydine, supporting manufacturing, laboratory and logistics teams to assess, select and validate computerized systems used in GMP processes.

Key responsibilities

• Act as a change driver and strategic lead within the global Quality Management System framework.
• Introduce strategic initiatives to standardise GMP computerized systems, data integrity and master data management across the site.
• Provide quality oversight, data‑integrity guidance and support inspection readiness for computerized systems.
• Collaborate with business units to resolve regulatory non‑conformances and drive continuous improvement.

Required profile

• Bachelor’s degree in Science, IT, Engineering or equivalent.
• At least five years of experience delivering validated IT solutions or supporting applications in a GxP environment.
• Strong knowledge of pharmaceutical regulations (FDA/EU/ICH) and quality systems.
• Proven analytical, problem‑solving and project‑management skills.

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