GxP Validation Lead - Systems & Compliance

RiseMe; Birmingham (AL); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

Life insurance

Paid time off

Employee assistance program

Job summary

Southern Research + You seeks a Senior Validation Analyst to lead strategic validation initiatives for new GxP technologies in a regulated environment. You will partner with Business, IT, and Quality teams to define processes and author validation deliverables from planning through retirement, ensuring systems stay validated across their lifecycle.

The role requires strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP, plus hands-on experience with LIMS and laboratory systems.

Qualifications

• Bachelor's degree in a related field; 8+ years in Quality or Technical roles with validation leadership.
• Experience with validation, administration, operation, or maintenance of LIMS and other GxP systems.
• Advanced knowledge of pharmaceutical/CRO regulations (GxP, 21 CFR Part 11, EU Annex 11).
• Strong ability to manage multiple projects and collaborate with cross-functional teams.

Responsibilities

• Lead system validation efforts including strategy, risk management, and project management.
• Develop and maintain validation deliverables: Validation Plan, URS, Configuration Specification, Testing Strategy, Test Scripts with Traceability, Validation Summary Reports.
• Support lifecycle activities: change management, periodic reviews, and retirement planning.
• Investigate incidents, determine root causes, implement corrective actions and controls.
• Coordinate audit readiness and contribute to client/regulatory audit responses.

Skills

Regulatory compliance

LIMS validation

Project management

GxP environments

Validation testing

Education

Bachelor's degree in computer science or life sciences, related field

Tools

LIMS

Veeva Quality

Provantis

Benchling

Job description

Southern Research + You seeks a Senior Validation Analyst to lead strategic validation initiatives for new GxP technologies in a regulated environment. You will partner with Business, IT, and Quality teams to define processes and author validation deliverables from planning through retirement, ensuring systems stay validated across their lifecycle.

The role requires strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP, plus hands-on experience with LIMS and laboratory systems.