GxP IT Business Analyst & Validation Lead

TEKsystems; Lexington (MA); On-site; USD 83,000 - 103,000; Full time

Job summary

TEKsystems seeks an experienced SR IT Business Analyst & GxP Systems Manager to lead analysis, compliance, and support for validated GLP/GMP systems. You will partner with QA, RA/RegOps, Manufacturing, and Quality Control to drive compliant solutions.

Responsibilities include requirements gathering, system design, validation coordination, and lifecycle management across validated platforms, with focus on inspection readiness.

Qualifications

• 8+ years IT BA experience supporting enterprise applications and processes.
• 5+ years in GxP-regulated environments (GLP/GMP).
• Hands-on CSV and CSA methodologies experience.
• Strong knowledge of FDA 21 CFR Part 11, GAMP 5, ALCOA+.

Responsibilities

• Serve as the primary IT business partner for QA and Regulatory Affairs/Operations teams.
• Lead requirements gathering through workshops and interviews.
• Translate business needs into compliant system requirements and specs.
• Facilitate collaboration among stakeholders, IT, validation, and vendors.
• Lead medium to large-scale regulated system initiatives.
• Develop roadmaps and long-term system improvement plans.
• Oversee validation, upgrades, integrations, and lifecycle management.
• Drive prioritization balancing value, compliance, and resources.
• Support CSV/CSA, including URS, risk assessments, traceability, and IQ/OQ/PQ.
• Ensure inspection readiness and regulatory inquiries are addressed.

Skills

Business Analysis

Requirements Gathering

GxP Compliance

CSV

CSA

QMS

Project Management

Regulatory Compliance

Data Integrity ALCOA+

Stakeholder Management

Education

Bachelor's degree in IS/CS/Engineering/Life Sciences

Master's degree in IS/Engineering/Life Sciences

Tools

QMS platforms

Regulatory systems

Job description

TEKsystems seeks an experienced SR IT Business Analyst & GxP Systems Manager to lead analysis, compliance, and support for validated GLP/GMP systems. You will partner with QA, RA/RegOps, Manufacturing, and Quality Control to drive compliant solutions.

Responsibilities include requirements gathering, system design, validation coordination, and lifecycle management across validated platforms, with focus on inspection readiness.