Manager, IT - GxP Systems & Compliance

Rocket Pharmaceuticals•Cranbury, NJ

1d•$120,000 - $160,000•Onsite

About The Position

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. The Manager will partner closely with Manufacturing, Quality Control, Quality Assurance, Validation, Automation, Facilities, and external service providers to maintain uptime, data integrity, security, and regulatory compliance for GxP systems. The role will support lifecycle activities for applications, laboratory instruments, manufacturing systems, connected devices, infrastructure components, and associated documentation in accordance with approved SOPs, GAMP 5 principles, 21 CFR Part 11, data integrity expectations, and applicable company quality standards. This role will provide technical and operational oversight for GxP support operations, ensuring effective incident management, service request fulfillment, access management, backup and restore oversight, patching coordination, periodic review support, change execution, deviation/CAPA support, and audit readiness for GxP computerized systems across manufacturing and laboratory environments. 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. Advanced degree a plus.
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.
Experience working in a collaborative, cross-functional, and quality-driven environment with a focus on service reliability, compliance, and continuous improvement.

Nice To Haves

Advanced degree a plus.

Responsibilities

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.
Partner with Manufacturing, QC, QA, Validation, Automation, Facilities, and business stakeholders to triage incidents, resolve service requests, manage escalations, and minimize operational disruption.
Support GxP change control activities, including impact assessment, implementation planning, testing coordination, validation deliverables, deployment readiness, and post-implementation verification.
Assist with computerized system validation and qualification activities, including IQ/OQ/PQ, user acceptance testing, traceability, periodic reviews, system retirement, and maintenance of audit-ready documentation.
Lead or support deviation, incident, problem, CAPA, and effectiveness check records related to GxP computerized systems and ensure timely completion of assigned actions.
Manage system administration processes for GXP applications, including user access provisioning, role-based access, periodic access reviews, audit trail support, backup and restore oversight, and data integrity controls.
Coordinate patching, vulnerability remediation, endpoint maintenance, server support, disaster recovery testing, and business continuity activities for GXP systems in alignment with IT and quality procedures.
Develop, maintain, and improve SOPs, work instructions, support runbooks, knowledge articles, system inventories, configuration records, and operational support procedures for GxP systems.
Manage relationships with vendors and external service providers to ensure timely support, compliant service delivery, effective issue escalation, and completion of maintenance or qualification activities.
Track and report GxP supports metrics, system health indicators, recurring issues, service levels, and continuous improvement opportunities to strengthen operational excellence.
Support internal audits, external inspections, vendor audits, and quality reviews by preparing documentation, responding to findings, and driving remediation activities related to GxP IT support operations.