Manager, IT - GxP Systems & Compliance

The Manager, IT - GxP Systems & Compliance, is responsible for ensuring reliable, complaint, and audit-ready IT support for GxP manufacturing, QC laboratory, and related technical operations systems. This individual will provide day-to-day operational support, system administration oversight, incident resolution, change control coordination, validation support, vendor coordination, and continuous improvement for computerized systems used in GxP operations.

What You Will Do

Provide daily IT operational support for GxP manufacturing, QC laboratory, and technical operations systems, including application issues, instrument-connected workstations, networked devices, infrastructure components, and user access requests. Maintain reliable, compliant, and secure operation of GxP systems such as LIMS, CDS, MES, BMS, SCADA, Empower, laboratory instruments, cleanroom systems, manufacturing systems, and related GxP applications.

Why It Might Be a Fit

The IT GXP Support Operations Manager ensures that GxP systems and related services meet business, quality, compliance, security, and end-user requirements. The role supports controlled changes, documented testing, system qualification activities, audit trail and access review processes, incident documentation, deviation investigations, and timely remediation of operational risks in partnership with IT, QA, Validation, Manufacturing, QC, and Automation teams.

Requirements

• Bachelor’s degree in information technology, Computer Science, Engineering, Life Sciences, or equivalent relevant experience
• 5-8 years of experience supporting IT systems in a GxP-regulated pharmaceutical, biotechnology, CDMO, manufacturing, or quality control environment
• Hands-on experience supporting GxP manufacturing, QC laboratory, automation, or IT/OT systems, including instrument-connected PCs, networked devices, servers, applications, and validated systems
• Working knowledge of cGXP, GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+, data integrity, computerized system validation, change control, deviation/CAPA, and audit readiness expectations
• Experience with GxP systems and platforms such as LIMS, CDS, MES, BMS, SCADA, Empower, laboratory instruments, manufacturing systems, Veeva Vault, eQMS, ERP, or similar regulated applications
• Experience with system administration, access management, backup and restore processes, patching coordination, disaster recovery, periodic reviews, audit trail support, and controlled documentation
• Ability to troubleshoot technical issues across applications, endpoints, infrastructure, laboratory instruments, and manufacturing support systems while maintaining compliance with approved procedures
• Strong documentation skills with experience creating or maintaining SOPs, work instructions, runbooks, validation documentation, support records, incident records, and audit-ready evidence
• Demonstrated ability to partner with Manufacturing, QC, QA, Validation, Automation, Facilities, Cybersecurity, Infrastructure, and vendor teams in a regulated operating environment
• Strong organizational, communication, problem-solving, customer service, and prioritization skills with the ability to support critical GxP operations

Benefits

• Competitive total rewards package
• Bonuses (short-term incentives)
• Medical, dental, and vision insurance
• Life insurance
• 401(k) with company match and generous vesting
• Paid vacation and holidays
• Global shutdown days between Christmas and New Year’s
• Wellness resources and employee support programs
• Equity awards (long-term incentives)