GxP IT Systems & Compliance Manager (Validation)

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

Benefits offered by this job

Equity participation

401(k) matching

Health benefits

Job summary

Rocket Pharmaceuticals in Cranbury, NJ, is seeking a Manager, IT - GxP Systems & Compliance to ensure reliable, compliant IT support for GxP manufacturing, QC labs, and related operations. You will manage incident resolution, validation, and lifecycle activities for regulated systems.

You will partner with Manufacturing, QC, QA, Validation, Automation, and external vendors to maintain data integrity, security, and regulatory compliance across LIMS, CDS, MES, BMS, and other GxP platforms.

Qualifications

• Bachelor's degree in IT, CS, engineering, life sciences or equivalent.
• 5-8 years IT systems experience in a GxP-regulated environment.
• Experience with GxP systems such as LIMS, CDS, MES, BMS, SCADA, Empower.
• Knowledge of 21 CFR Part 11, GAMP 5, data integrity and audit readiness.
• Strong documentation and audit readiness skills.

Responsibilities

• Provide daily IT operational support for GxP manufacturing, QC labs, and technical ops systems.
• Coordinate change control, validation activities, and testing deliverables.
• Ensure data integrity, access management, backup/restore oversight, and audit trails.
• Collaborate with Manufacturing, QC, QA, Validation, Automation, Facilities and vendors.
• Prepare for internal and external audits and inspections; maintain SOPs and runbooks.

Skills

GxP systems knowledge

Regulatory compliance

Incident management

Change control

Vendor coordination

Documentation skills

Cross-functional collaboration

Education

Bachelor’s degree in IT, CS, Engineering, Life Sciences

Advanced degree a plus

Tools

LIMS

CDS

MES

BMS

SCADA

Empower

Veeva Vault

eQMS

ERP

Job description

Rocket Pharmaceuticals in Cranbury, NJ, is seeking a Manager, IT - GxP Systems & Compliance to ensure reliable, compliant IT support for GxP manufacturing, QC labs, and related operations. You will manage incident resolution, validation, and lifecycle activities for regulated systems.

You will partner with Manufacturing, QC, QA, Validation, Automation, and external vendors to maintain data integrity, security, and regulatory compliance across LIMS, CDS, MES, BMS, and other GxP platforms.