What are the responsibilities and job description for the IT Systems Manager position at Insight Global?
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.
Salary : $68 - $92