IT Technical Program Manager (Java/Pharma Domain)

Quantum Technologies. LLC; New Jersey; On-site; USD 96,000 - 152,000; Full time

Job summary

A leading technology firm in New Jersey is seeking an IT Technical Program Manager to lead IT initiatives for digital platforms supporting cell therapy. This role requires significant IT experience, with a focus on regulatory compliance and cross-functional program leadership. The ideal candidate should have expertise in managing complex projects within the pharmaceutical sector, particularly in drug manufacturing and cell therapy environments. The role offers competitive hourly rates depending on experience.

Qualifications

• 15-17+ years of IT experience, 7+ years in technical program management.
• Experience in US pharma and drug manufacturing.
• Strong understanding of cell therapy environments.
• Familiarity with MES, LIMS, SAP, Scheduler and control system integration

Responsibilities

• Lead IT initiatives for digital platforms in pharma.
• Coordinate with cross-functional teams for project delivery.
• Ensure platforms are inspection-ready for regulatory audits.
• Embed GxP (21 CFR Part 11, Annex 11) requirements early during design
• Represent Digital in regulatory audits and inspections
• Drive cross-functional alignment and clear communication across teams
• Manage vendors and deliver on complex project scopes and timelines

Skills

Technical program management

Regulatory compliance

Cross-functional leadership

GxP regulations knowledge

Integration architectures

Vendor management

System integration

Tools

MES

LIMS

SAP

Scheduler

Control systems

Integration architectures

Job description

IT Technical Program Manager (Java/Pharma Domain)

Location: New Jersey, NJ

Duration: 12Months+ Extension

Hourly Rate: Depending on Experience (DOE)

Work Authorization:

Overview

Role Overview: Lead and oversee IT initiatives supporting cell therapy digital platforms that drive manufacturing, orchestration, integration, and compliance within regulated pharmaceutical environments—spanning vendor systems such as MES, LIMS, SAP, and scheduling systems.

Responsibilities

• Overall 15-17+ years of IT experience and 7+ year of experience in technical program management with deep experience in US pharma, Drug Manufacturing, Cell Therapy and US pharma regulations.
• Cross‑Functional Program Leadership
• Coordinate with Digital, Engineering, Quality, Regulatory, QA, and Manufacturing teams.
• Strong knowledge of GxP regulations, validation lifecycle, and digital manufacturing system landscapes.
• Experience with MES, LIMS, SAP, Scheduler, Control systems, integration architectures.
• Experience in personalized or cell therapy manufacturing environments.
• Familiarity with digital validation frameworks in CAR-T and related cell therapy platforms.
• Computer System Validation (CSV)
• Develop validation strategy and execute CSV planning across complex digital systems.
• Embed GxP (21 CFR Part 11, Annex 11) requirements early during design.
• Regulatory Readiness & Inspection Support
• Ensure platforms are inspection-ready for BLA submissions and manufacturing transitions.
• Represent Digital in regulatory audits and inspections.
• Technical and Architectural Oversight
• Engage in technical design/architecture discussions to de-risk validation.
• Ensure integration readiness across systems (e.g., mINT Engine, Scheduler, Control Tower).
• Business Engagement & Leadership
• Able to drive cross-functional alignment and clear communication across scientific, operational, IT, and QA/regulatory teams.
• Capable of managing vendors, delivering on complex project scopes, milestones, timelines.

Qualifications

Required Technical Expertise:

QUANTUM TECHNOLOGIES LLC is an equal opportunity employer inclusive of female, minority, disability and veterans, (M/F/D/V). Hiring, promotion, transfer, compensation, benefits, discipline, termination and all other employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, citizenship/immigration status, veteran status or any other protected status. QUANTUM TECHNOLOGIES LLC will not make any posting or employment decision that does not comply with applicable laws relating to labor and employment, equal opportunity, employment eligibility requirements or related matters. Nor will QUANTUM TECHNOLOGIES LLC require in a posting or otherwise U.S. citizenship or lawful permanent residency in the U.S. as a condition of employment except as necessary to comply with law, regulation, executive order, or federal, state, or local government contract