Senior IT Program Manager, Pharma & Cell Therapy

Valiant Technologies LLC; New Jersey; On-site; USD 110,000 - 165,000; Full time

Job summary

VALIANT TECHNOLOGIES LLC in New Jersey is seeking an IT Technical Program Manager (Java/Pharma Domain) to lead IT initiatives for cell therapy digital platforms within regulated pharmaceutical environments. You will oversee systems like MES, LIMS, SAP, and scheduling, ensuring compliance and audit readiness.

The role requires 15+ years IT experience with 7+ years in technical program management in pharma, strong cross-functional bridge-building, and deep knowledge of GxP regulations and CSV.

Qualifications

• Overall 15+ years IT experience and 7+ years in technical program management in pharma.
• Deep experience in US pharma, drug manufacturing, cell therapy, and US pharma regulations.
• Experience with MES, LIMS, SAP, and scheduling systems.
• Familiarity with GxP, validation lifecycle, and digital manufacturing system landscapes.
• Experience in cell therapy manufacturing environments.
• CSV and validation strategy development.
• Embed 21 CFR Part 11, Annex 11 requirements early in design.

Responsibilities

• Lead cross-functional program leadership across Digital, Engineering, Quality, Regulatory, QA, and Manufacturing.
• Oversee IT initiatives supporting cell therapy digital platforms and manufacturing systems.
• Coordinate with Digital, Engineering, Quality, Regulatory, QA, and Manufacturing teams.
• Develop validation strategy and execute CSV planning across complex digital systems.
• Ensure platforms are inspection-ready for BLA submissions and manufacturing transitions.
• Represent Digital in regulatory audits and inspections.
• Provide technical and architectural oversight to de-risk validation and ensure system integration readiness across MES, Scheduler, and Control Tower.
• Manage vendors and deliver on complex project scopes and milestones.

Skills

Program management

GxP regulations

CSV

Digital manufacturing

Vendor management

Tools

MES

LIMS

SAP

Scheduler

Control systems

Job description

VALIANT TECHNOLOGIES LLC in New Jersey is seeking an IT Technical Program Manager (Java/Pharma Domain) to lead IT initiatives for cell therapy digital platforms within regulated pharmaceutical environments. You will oversee systems like MES, LIMS, SAP, and scheduling, ensuring compliance and audit readiness.

The role requires 15+ years IT experience with 7+ years in technical program management in pharma, strong cross-functional bridge-building, and deep knowledge of GxP regulations and CSV.