Senior Digital & Data Quality Lead – GMP & DI

MSD; Ireland; On-site; EUR 90,000 - 120,000; Full time

Job summary

MSD is seeking a Senior Specialist for Digital and Data Quality at Ballydine to oversee data integrity and computerized systems validation supporting GMP processes. You will guide QA activities, ensure regulatory compliance and contribute to inspection readiness across site facilities and labs.

The role requires strong analytical skills, expertise in cGMP, and collaboration with manufacturing, laboratory and logistics teams to standardise data integrity practices.

Qualifications

• Bachelor’s degree in Science, IT, Engineering or equivalent.
• 5+ years delivering validated IT solutions or supporting applications.
• Strong understanding of pharma regulations (FDA/EU/ICH).
• Experience implementing quality systems in pharma, lab or manufacturing.

Responsibilities

• Lead quality aspects of data integrity, GMP CIM systems and master data management.
• Review and approve quality activities, policies, procedures and deviations; support inspection readiness.
• Drive standardisation of GMP computerized systems and data integrity across DDQ governance.
• Develop and maintain training on computerized systems validation and data integrity.

Skills

Data integrity

GxP compliance

Quality management

Education

Bachelor’s degree

Job description

MSD is seeking a Senior Specialist for Digital and Data Quality at Ballydine to oversee data integrity and computerized systems validation supporting GMP processes. You will guide QA activities, ensure regulatory compliance and contribute to inspection readiness across site facilities and labs.

The role requires strong analytical skills, expertise in cGMP, and collaboration with manufacturing, laboratory and logistics teams to standardise data integrity practices.