IT QA Lead for GxP Systems & Validation

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, 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.