IT Technical Program Manager (Java/Pharma Domain)

Cloud Analytics Technologies, LLC; New Jersey; On-site; USD 124,000 - 165,000; Full time

Job summary

A leading healthcare technology firm is seeking an IT Technical Program Manager in New Jersey to lead IT initiatives supporting cell therapy digital platforms. This role involves managing cross-functional teams, ensuring compliance with GxP regulations, and overseeing technical architecture discussions. The ideal candidate will have 15+ years of IT experience with a strong background in pharmaceutical environments and validation processes. Competitive salary and hourly rate based on experience offered.

Qualifications

• 15-17+ years of IT experience with 7+ years in technical program management.
• Experience in US pharma regulations and cell therapy.
• Strong knowledge of validation lifecycle and digital manufacturing systems.

Responsibilities

• Lead IT initiatives for cell therapy digital platforms.
• Ensure platforms are inspection-ready for audits.
• Drive cross-functional team alignment.
• Embed GxP (21 CFR Part 11, Annex 11) requirements early during design.
• Regulatory readiness and inspection support; ensure platforms are inspection-ready for BLA submissions and manufacturing transitions.
• Represent Digital in regulatory audits and inspections.
• Engage in technical design/architecture discussions to de-risk validation and ensure integration readiness across systems.

Skills

IT program management

Cross-functional leadership

GxP regulations knowledge

Computer System Validation (CSV)

Integration architectures

Pharmaceutical regulations experience

Tools

MES

LIMS

SAP

Scheduler

Job description

IT Technical Program Manager (Java/Pharma Domain)

Location: New Jersey, NJ

Duration: 12Months+ Extension

Hourly Rate: Depending on Experience (DOE)

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.

Key Responsibilities

• Overall 15-17+ years of IT experience and 7+ years 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.

Equal Opportunity Employer

CLOUD ANALYTICS 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. CLOUD ANALYTICS 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 CLOUD ANALYTICS 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.