Information Technology Governance Consultant

About the role

CYVEX is seeking an experienced freelance consultant to assess and improve IT governance and GxP compliance within the pharmaceutical sector. The role focuses on evaluating policies, controls, and validation practices to ensure regulatory audit readiness.

Key responsibilities

• Review and assess IT policies, procedures, and governance frameworks against regulatory requirements and industry standards.
• Conduct IT compliance gap assessments and support regulatory audit readiness.
• Assess Computerized System Validation (CSV) practices, including ERP and other GxP‑relevant systems.
• Evaluate IT controls related to access management, change management, data integrity, and system security.
• Develop actionable recommendations and support policy enhancements and remediation planning.

Required profile

• Proven experience in IT Governance, IT Audit, Risk Management, and Compliance.
• Demonstrated knowledge of pharmaceutical GxP requirements, particularly EU GMP Annex 11.
• Experience with CSV, GAMP 5, and data integrity principles (ALCOA+).
• Familiarity with ISO 27001/27002 and other recognized IT governance and cybersecurity frameworks.
• Previous involvement in pharmaceutical regulatory audits or audit‑readiness assessments is highly desirable.

Required skills

• IT Governance
• IT Audit
• Risk Management
• Compliance
• GxP (EU GMP Annex 11)
• Computerized System Validation (CSV)
• GAMP 5
• ALCOA+ data integrity
• ISO 27001
• ISO 27002