Manager, IT - GxP Systems & Compliance
Rocket Pharmaceuticals
August 11, 2026
On-site
Cranbury, NJ
IT
Position Summary:
Manager, IT – GxP Systems & Compliance responsible for reliable, compliant, and audit-ready IT support for GxP manufacturing, QC laboratory, and related technical operations systems. Provides 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.
Responsibilities:
- Provide daily IT operational support for GxP systems (applications, instrument-connected workstations, networked devices, infrastructure, user access requests).
- Maintain secure, compliant operation of GxP systems (e.g., LIMS, CDS, MES, BMS, SCADA, Empower, instruments, cleanroom and manufacturing systems).
- Triage incidents, resolve service requests, manage escalations with stakeholders (Manufacturing, QC, QA, Validation, Automation, Facilities).
- Support GxP change control (impact assessment, testing coordination, validation deliverables, deployment readiness, post-implementation verification).
- Assist computerized system validation/qualification (IQ/OQ/PQ, UAT, traceability, periodic reviews, retirement, audit-ready documentation).
- Lead/support deviation/incident/problem/CAPA/effectiveness checks and ensure timely actions.
- Manage access management and data integrity controls (provisioning, role-based access, access reviews, audit trail support, backup/restore oversight).
- Coordinate patching, vulnerability remediation, maintenance, disaster recovery testing, and business continuity.
- Develop/maintain SOPs, runbooks, knowledge articles, inventories, configuration records, and operational support procedures.
- Manage vendors for compliant service delivery and issue escalation.
- Track/report GxP support metrics; support internal/external audits and remediation.
Qualifications:
- Bachelor’s degree (IT, CS, Engineering, Life Sciences) or equivalent; advanced degree a plus.
- 5–8 years supporting IT systems in GxP-regulated pharma/biotech/CDMO/manufacturing/QC.
- Hands-on support of GxP manufacturing/QC/automation/IT-OT systems (validated systems, servers, applications, instrument-connected PCs, networked devices).
- Knowledge of cGXP, GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+, data integrity, computerized system validation, change control, deviation/CAPA, audit readiness.
- Experience with GxP platforms (LIMS, CDS, MES, BMS, SCADA, Empower, instruments, manufacturing systems, Veeva Vault, eQMS, ERP or similar).
- Experience with system administration, access management, backup/restore, patching, disaster recovery, periodic reviews, audit trail support, controlled documentation.
- Strong troubleshooting, documentation, organizational/communication/customer service, and prioritization skills.
- Ability to work cross-functionally in a quality-driven, compliance-focused environment.
Benefits (explicitly stated):
- Salary range: $120,000–$160,000.
- Total rewards may include bonuses, medical/dental/vision, life insurance, 401(k) with match, paid vacation/holidays, global shutdown days, wellness resources, and possible equity awards.
Physical requirements:
- Occasional work outside standard hours; lift/carry equipment up to 25 lbs (occasional); PPE; work in office and regulated lab/manufacturing/data center environments.
Manager, IT – GxP Systems & Compliance responsible for reliable, compliant, and audit-ready IT support for GxP manufacturing, QC laboratory, and related technical operations systems. Provides 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.
Responsibilities:
- Provide daily IT operational support for GxP systems (applications, instrument-connected workstations, networked devices, infrastructure, user access requests).
- Maintain secure, compliant operation of GxP systems (e.g., LIMS, CDS, MES, BMS, SCADA, Empower, instruments, cleanroom and manufacturing systems).
- Triage incidents, resolve service requests, manage escalations with stakeholders (Manufacturing, QC, QA, Validation, Automation, Facilities).
- Support GxP change control (impact assessment, testing coordination, validation deliverables, deployment readiness, post-implementation verification).
- Assist computerized system validation/qualification (IQ/OQ/PQ, UAT, traceability, periodic reviews, retirement, audit-ready documentation).
- Lead/support deviation/incident/problem/CAPA/effectiveness checks and ensure timely actions.
- Manage access management and data integrity controls (provisioning, role-based access, access reviews, audit trail support, backup/restore oversight).
- Coordinate patching, vulnerability remediation, maintenance, disaster recovery testing, and business continuity.
- Develop/maintain SOPs, runbooks, knowledge articles, inventories, configuration records, and operational support procedures.
- Manage vendors for compliant service delivery and issue escalation.
- Track/report GxP support metrics; support internal/external audits and remediation.
Qualifications:
- Bachelor’s degree (IT, CS, Engineering, Life Sciences) or equivalent; advanced degree a plus.
- 5–8 years supporting IT systems in GxP-regulated pharma/biotech/CDMO/manufacturing/QC.
- Hands-on support of GxP manufacturing/QC/automation/IT-OT systems (validated systems, servers, applications, instrument-connected PCs, networked devices).
- Knowledge of cGXP, GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+, data integrity, computerized system validation, change control, deviation/CAPA, audit readiness.
- Experience with GxP platforms (LIMS, CDS, MES, BMS, SCADA, Empower, instruments, manufacturing systems, Veeva Vault, eQMS, ERP or similar).
- Experience with system administration, access management, backup/restore, patching, disaster recovery, periodic reviews, audit trail support, controlled documentation.
- Strong troubleshooting, documentation, organizational/communication/customer service, and prioritization skills.
- Ability to work cross-functionally in a quality-driven, compliance-focused environment.
Benefits (explicitly stated):
- Salary range: $120,000–$160,000.
- Total rewards may include bonuses, medical/dental/vision, life insurance, 401(k) with match, paid vacation/holidays, global shutdown days, wellness resources, and possible equity awards.
Physical requirements:
- Occasional work outside standard hours; lift/carry equipment up to 25 lbs (occasional); PPE; work in office and regulated lab/manufacturing/data center environments.