GxP IT Systems & Compliance Leader

Rocket Pharma; Cranbury Township (NJ); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Paid vacation and holidays

Equity opportunities

Job summary

Rocket Pharma seeks an IT - GxP Systems & Compliance Manager to ensure reliable, compliant IT support for GxP manufacturing and QC operations. You will oversee system administration, incident resolution, validation support, and vendor coordination to sustain data integrity and regulatory readiness.

You will partner with Manufacturing, QA, Validation, Automation, Facilities, and external providers to maintain uptime and security across LIMS, CDS, MES, and related systems, aligning with GAMP 5 and

Qualifications

• Bachelor's degree in information technology, Computer Science, Engineering, Life Sciences, or equivalent experience.
• 5–8 years of experience supporting IT systems in a GxP-regulated environment.
• Hands-on experience with GxP systems and platforms such as LIMS, CDS, MES, BMS, SCADA, Empower, laboratory instruments, and manufacturing systems.
• Knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, data integrity, validation, change control, deviation/CAPA, and audit readiness.

Responsibilities

• Provide daily IT operational support for GxP manufacturing, QC laboratory, and technical operations systems.
• Maintain compliant and secure operation of GxP systems (LIMS, CDS, MES, BMS, SCADA, Empower).
• Partner with multiple stakeholders to triage incidents, resolve service requests, and manage escalations.
• Support GxP change control activities, including validation deliverables and deployment readiness.
• Assist with validation/qualification activities (IQ/OQ/PQ) and audit-ready documentation.
• Lead or support CAPA, deviation, and corrective actions related to GxP systems.
• Manage user access provisioning, backups, patching, and disaster recovery for GxP applications.

Skills

Incident management

Change control

Documentation

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's degree in IT/CS/Engineering/Life Sciences

Advanced degree is a plus

Tools

LIMS

CDS

MES

BMS

SCADA

Empower

Veeva Vault/eQMS/ERP

Job description

Rocket Pharma seeks an IT - GxP Systems & Compliance Manager to ensure reliable, compliant IT support for GxP manufacturing and QC operations. You will oversee system administration, incident resolution, validation support, and vendor coordination to sustain data integrity and regulatory readiness.

You will partner with Manufacturing, QA, Validation, Automation, Facilities, and external providers to maintain uptime and security across LIMS, CDS, MES, and related systems, aligning with GAMP 5 and