IT/OT Lab Systems Lead: GMP & Compliance

U061 (FCRS = US061) Novartis Services, Inc.; Durham (NC); On-site; USD 109,000 - 202,000; Full time

Job summary

Novartis Services, Inc. in Durham, NC seeks an IT/OT Senior Lab Specialist to lead strategy, implementation, and lifecycle management of computerized laboratory systems across GMP and non-GMP environments.

You will collaborate with cross-functional teams to ensure instrument availability, regulatory compliance, and continuous improvement. You will lead change controls, document URS/FS/DDS, and support inspections and CAPA processes while coordinating with vendors and site partners to achieve

Qualifications

• B.S. degree in Engineering, Computer Science, IT or related technical field.
• 8 years' work experience in pharmaceutical/biopharmaceutical lab operations (or 12 years equivalent).
• Experience leading teams installing, configuring and maintaining lab systems in a GMP environment.
• Knowledge of FDA regulations, especially 21 CFR Part 11, and GMP systems.

Responsibilities

• Lead design, configuration, installation, and maintenance of lab instrumentation software and hardware.
• Ensure lab instruments maintain high availability; coordinate with vendors as needed.
• Participate as SME in health authority and internal inspections; drive CAPA closures.
• Lead instrument change controls; document URS, FS and DDS/SDS; support cross-functional prioritization.
• Collaborate with partners; support 24x7 site operations and on-call rotations.

Skills

Regulatory compliance

GxP knowledge

CAPA management

Vendor management

Project management

Quality management

Risk management

Stakeholder management

Decision making

Operational excellence

Education

B.S. degree in Engineering, Computer Science, IT or related technical field

Job description

Novartis Services, Inc. in Durham, NC seeks an IT/OT Senior Lab Specialist to lead strategy, implementation, and lifecycle management of computerized laboratory systems across GMP and non-GMP environments.

You will collaborate with cross-functional teams to ensure instrument availability, regulatory compliance, and continuous improvement. You will lead change controls, document URS/FS/DDS, and support inspections and CAPA processes while coordinating with vendors and site partners to achieve