Manager, IT - GxP Systems & Compliance

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

Overview

Create a future where DNA is no longer destiny. Join Rocket Pharma.

Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits.

Position Summary

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.

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.

Qualifications

• 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.

Physical Requirements:

• Ability to work outside of standard business hours on an occasional basis to support GxP activities, system implementations, upgrades, maintenance activities, audits, inspections, and critical issue resolution.
• Ability to lift, carry, push, and/or pull equipment and materials weighing up to 25 pounds on an occasional basis.
• Ability to wear required personal protective equipment (PPE) and comply with all safety, security, and GxP requirements while working in regulated environments
• Ability to work in both office and regulated laboratory, manufacturing, and data center environments.

Compensation

The expected salary range for this position is $120,000 to $160,000.

At Rocket, our compensation philosophy and ranges are built upon data and insights collected from validated world-class providers. We are committed to compensating employees equitably based on several factors, including responsibilities and level of the position, depth and types of the employee’s experience, location of the position and availability of similar talent in a competitive market.

For U.S.-based candidates, this is an at-will position, and Rocket reserves the right to adjust the range at hire or during the year due to market shifts.

In addition to base salary, Rocket offers a competitive total rewards package that may include 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, and a variety of wellness resources and employee support programs. Also, certain positions are eligible for added forms of compensation, such equity awards (long-term incentives).

EEO Statement

A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.