IT QA Lead

United Consulting Hub, Inc.; New Jersey; On-site; USD 120,000 - 160,000; Full time

Job summary

United Consulting Hub, Inc. delivers specialized validation and quality solutions across the life sciences industry, supporting clients with Computer Systems Validation, Equipment & Process Validation, QA, QC, Microbiology, and Regulatory Affairs.

We are seeking an experienced IT Quality Assurance Specialist / Lead to support GxP computerized systems and IT compliance within a pharmaceutical manufacturing environment.

Qualifications

• 5–10 years of IT QA, CSV, CSA, or GxP IT Compliance.
• Pharma/regulated life sciences experience.
• Strong CSV and CSA knowledge.
• Familiar with GAMP 5, 21 CFR Part 11, Annex 11, ICH Q9/Q10, ALCOA+.
• Experience reviewing URS, validation plans, risk assessments, IQ/OQ/PQ, RTM, reports.
• Experience with GxP systems (SAP/ERP, MES, LIMS, QMS, DMS, SCADA, BMS, EMS, data historians).
• Audits/regulatory inspection support knowledge.
• Supplier/vendor qualification and cloud compliance.
• Clear documentation and stakeholder-management skills.

Responsibilities

• Support GxP computerized systems and IT compliance in manufacturing.
• Provide quality oversight across validation, data integrity, change control, deviations, CAPA, audits, and lifecycle activities.
• Collaborate with QA and IT teams to maintain compliant systems.

Skills

IT QA

CSV

CSA

GxP IT

Validation

Data integrity

Audit trails

Change control

CAPA

Regulatory support

Documentation

Stakeholder mgmt

Tools

SAP/ERP

MES

LIMS

QMS

DMS

SCADA

BMS

EMS

Data historians

Job description

United Consulting Hub delivers specialized validation and quality solutions across the life sciences industry, supporting clients with Computer Systems Validation, Equipment & Process Validation, QA, QC, Microbiology, and Regulatory Affairs.

Job Description

We are seeking an experienced IT Quality Assurance Specialist / Lead to support GxP computerized systems and IT compliance within a pharmaceutical manufacturing environment. The role will provide quality oversight across validation, data integrity, change control, deviations, CAPA, audits, and system lifecycle activities.

Position: IT Quality Assurance Specialist / Lead

Industry: Pharmaceutical Manufacturing

Location: NJ

Key Experience

• 5–10 years of experience in IT QA, CSV, CSA, or GxP IT Compliance
• Pharmaceutical, biotech, medical device, or regulated life-sciences experience
• Strong experience with Computerized System Validation (CSV) and Computer Software Assurance (CSA)
• Knowledge of GAMP 5, FDA 21 CFR Part 11, 210/211, EU GMP Annex 11, ICH Q9/Q10, and ALCOA+
• Experience reviewing URS, validation plans, risk assessments, FS/DS, IQ/OQ/PQ, RTM, and validation reports
• Experience with GxP systems such as SAP/ERP, MES, LIMS, QMS, DMS, SCADA, BMS, EMS, and data historians
• Strong understanding of data integrity, audit trails, access controls, backup/recovery, electronic records, and system security
• Experience with change control, deviations, CAPA, periodic reviews, incident management, and system decommissioning
• Audit and regulatory inspection support experience
• Experience with supplier/vendor qualification and cloud technology compliance
• Strong documentation, communication, risk assessment, and stakeholder-management skills

Preferred Certifications

• GAMP 5 / CSV certification
• ASQ Certified Quality Auditor
• ITIL Foundation
• ISO 27001 / CISA / CISSP
• Project Management or Agile certification