Tech Compliance Leader - CSV/SDLC Expert (Hybrid)

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

Job summary

Caraway Therapeutics, Inc. in Dublin, Ireland, seeks a Senior Technology Compliance Specialist to provide IT compliance/validation support for the DMO team and site operations.

The role emphasizes CSV/SDLC, data integrity, cybersecurity, and regulatory alignment within a biotech manufacturing environment. The successful candidate will ensure regulatory compliance, manage audit readiness, and serve as SME for validation processes, while collaborating across technical and quality functions in a

Qualifications

• GxP experience in Computer System Validation (life sciences, pharma, or medical devices).
• Ability to collaborate across technical, quality and business functions in a dynamic environment.
• Experience supporting computerized systems compliance activities within manufacturing, quality, laboratory, or supply chain environments.

Responsibilities

• Ensure compliance with Global SDLC/CSV, Data Integrity, and IT Security policies and regulatory requirements.
• Plan and execute project and compliance deliverables including change control, periodic reviews, access management, disaster recovery, deviations, and CAPAs.
• Maintain compliance activities for computerized systems: changes, periodic reviews, audits, cybersecurity controls, and policy deployment.
• Act as SME for DMO-owned compliance and validation processes, guiding validation strategy and risk management.
• Maintain inspection readiness through 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 qualification in Science, Engineering, Information Technology, or related technical discipline

Job description

Caraway Therapeutics, Inc. in Dublin, Ireland, seeks a Senior Technology Compliance Specialist to provide IT compliance/validation support for the DMO team and site operations.

The role emphasizes CSV/SDLC, data integrity, cybersecurity, and regulatory alignment within a biotech manufacturing environment. The successful candidate will ensure regulatory compliance, manage audit readiness, and serve as SME for validation processes, while collaborating across technical and quality functions in a