Regulatory IT Compliance & CSV Specialist

Caraway Therapeutics, Inc.; Dublin; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Caraway Therapeutics, Inc. in Dublin, Ireland, seeks a Technology Compliance Specialist to safeguard CSV/SDLC and IT security across the site. The role ensures compliance with EU Annex 11, 21 CFR Part 11, and data integrity requirements, while supporting regulatory audits and inspections.

The position collaborates with Quality, Manufacturing, and IT to maintain inspection readiness and drive continuous improvement in a fast-paced biopharma environment.

Qualifications

• Degree in Science, Engineering, IT or related technical discipline.
• Minimum 3 years' CSV experience in a GxP-regulated environment.
• Strong knowledge of CSV, Data Integrity, SDLC, and regulatory requirements.
• Collaborates effectively across technical, quality and business functions.
• Excellent verbal and written communication with stakeholders.

Responsibilities

• Ensure compliance with Global SDLC/CSV, Data Integrity, and IT Security policies.
• Execute and maintain compliance activities for computerized systems, including change controls and disaster recovery.
• Support regulatory audits and inspections; act as liaison for auditor requests and documentation.
• Serve as SME for DMO-owned compliance and validation processes and risk management.
• Maintain inspection readiness through periodic reviews and mock audits.

Skills

Annex 11

Information Technology (IT) Projects

IT Compliance Management

IT Maintenance

Regulatory Audits

Stakeholder Management

Education

Science/Engineering/IT degree

Job description

Caraway Therapeutics, Inc. in Dublin, Ireland, seeks a Technology Compliance Specialist to safeguard CSV/SDLC and IT security across the site. The role ensures compliance with EU Annex 11, 21 CFR Part 11, and data integrity requirements, while supporting regulatory audits and inspections.

The position collaborates with Quality, Manufacturing, and IT to maintain inspection readiness and drive continuous improvement in a fast-paced biopharma environment.