Qualifications :
- Bachelor's Degree in Engineering, Computer Science, or related field.
- Minimum 5+ years in IT systems management within a cGMP pharmaceutical environment.
- Proven expertise in computer system validation (CSV), data integrity, and compliance frameworks.
- Strong knowledge of IT security principles and regulatory guidelines.
- Ability to lead cross-functional teams and manage complex technical environments.
- Knowledge of industrial control systems, automation platforms (e.g., DeltaV, Syncade).
- Experience with aseptic production systems preferred.
Job Description :
Insight Global is seeking an IT Systems Manager for a pharmaceutical client in the Raleigh area. The IT Systems Manager will lead and manage GxP-compliant IT systems and computerized equipment supporting aseptic and finished production environments. This role ensures operational excellence, regulatory compliance, and secure system performance across critical pharmaceutical manufacturing processes.
Key Responsibilities
Oversee delivery of lifecycle project work packages for IT systems and computerized equipment in production facilities.Implement and maintain GxP compliance through risk-based validation processes (ASTM E2500, GAMP 5).Conduct data integrity and IT security risk assessments; develop and implement mitigation strategies.Manage operation and maintenance of industrial control systems, ensuring secure and reliable performance.Lead change control processes and maintain accurate system documentation.Provide coaching and mentoring to technical staff; foster a culture of quality and compliance.Perform periodic reviews, audit trail analysis, and ensure adherence to regulatory standards (EMA, MHRA, OECD-17, PIC / S).Develop disaster recovery and backup strategies to safeguard critical systems.