Tech Compliance Lead: CSV, SDLC & Data Integrity

Msd Ireland; Dublin; Hybrid; EUR 70,000 - 110,000; Full time

Job summary

MSD Ireland in Dublin is seeking a Senior Technology Compliance Specialist to strengthen CSV, SDLC, and IT security across the Biotech site. The role focuses on delivering compliant IT systems that support biologics manufacturing and product quality.

You will drive data integrity, change controls, disaster recovery, and audit readiness while guiding validation strategy and risk management. A hybrid work model is offered; discuss flexibility during the recruitment process.

Qualifications

• Degree/Credentials in Science, Engineering, IT, or related technical discipline.
• 5-7 years of GxP experience in computer system validation (life science, pharma, medical devices).
• Experience collaborating across technical, quality, and business functions in a dynamic environment.

Responsibilities

• Ensure compliance with Global SDLC/CSV, Data Integrity, and IT Security policies, procedures, and regulatory requirements.
• Manage compliance components for deliverables: change control, periodic reviews, access management, disaster recovery, deviations, CAPAs, audits, cybersecurity controls, policy deployment, training, system administration.
• Act as SME for DMO-owned compliance and validation processes, guiding validation strategy and risk management.
• Maintain inspection readiness through periodic reviews, mock audits, and proactive remediation of gaps.

Skills

Audit Management

Change Controls

Collaborative Leadership

Compliance Monitoring

Data Integrity

Data Security

EU Annex 11

Policy and process development

Software Development Life Cycle (SDLC)

Stakeholder Management

Validation Processes

Education

Degree in Science/Engineering/IT

Job description

MSD Ireland in Dublin is seeking a Senior Technology Compliance Specialist to strengthen CSV, SDLC, and IT security across the Biotech site. The role focuses on delivering compliant IT systems that support biologics manufacturing and product quality.

You will drive data integrity, change controls, disaster recovery, and audit readiness while guiding validation strategy and risk management. A hybrid work model is offered; discuss flexibility during the recruitment process.