IT Systems Manager

We are seeking an experienced IT Systems Manager to support a major expansion project for a reputable pharmaceutical client in Clayton, NC.

This role involves managing multiple IT systems, overseeing project deliverables, and ensuring compliance with both client and regulatory requirements.

The IT Systems Manager will report to the IT/Automation team and is expected to complete tasks within scope, budget, and timeline.

Key Responsibilities

• Manage and oversee multiple IT systems simultaneously throughout the project lifecycle.
• Drive project deliverables and ensure alignment with business and regulatory requirements.
• Partner with key stakeholders to ensure successful execution and system integration.
• Ensure compliance with IT frameworks and regulatory standards including COBIT, ITIL, GAMP, 21 CFR Part 11, and/or PIC/S Annex 11.
• Support the system development lifecycle including validation, operation, maintenance, and decommissioning.
• Apply expert GxP documentation practices across all IT systems.
• Collaborate with project teams to drive computer system validation deliverables and activities.
• Provide technical leadership in manufacturing environments including aseptic processing, inspection, assembly, packaging, utilities, and laboratories.

• Proven experience in IT project management and system oversight within production manufacturing environments.
• Strong understanding of IT frameworks and regulatory standards (COBIT, ITIL, GAMP, 21 CFR Part 11, PIC/S Annex 11).
• Experience with system development lifecycle and computer system validation.
• Familiarity with pharmaceutical manufacturing processes.
• Expertise in GxP documentation practices.
• Ability to work 100% onsite in Clayton, NC.

• Background in pharmaceutical industry projects.
• Experience supporting IT/Automation teams in regulated environments.

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