Senior Validation Lead, GxP Systems & Compliance

Southern Research; Birmingham (AL); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

Life insurance

Paid time off

Job summary

Southern Research is seeking a Senior Validation Analyst to lead strategic validation efforts for GxP technologies. You will collaborate with Business, IT, and Quality teams to define requirements and deliver validation artifacts through the system lifecycle.

The role requires deep regulatory knowledge (GxP, Part 11, EU Annex 11) and the ability to manage multiple validation initiatives while ensuring systems stay in a validated state.

Qualifications

• Bachelor’s degree in computer science, life sciences, or related field.
• 8+ years in Quality or IT roles with validation leadership.
• Experience with LIMS or other GxP computer systems.
• Advanced knowledge of GxP regulations and 21 CFR Part 11.
• Strong interpersonal skills and client-focused approach.
• Ability to manage multiple projects and meet deadlines.
• Independent work style with collaborative teamwork.

Responsibilities

• Lead system validation efforts including strategy, risk management, and project management.
• Develop and maintain validation deliverables (Validation Plan, URS, Configuration, Testing, Traceability, Summary Reports, Commissioning documents).
• Collaborate with Business, IT, and Quality teams to implement technologies in GxP environments.
• Support change management and Periodic Review to sustain validated state.
• Investigate validation incidents and determine corrective actions.
• Support audits and regulatory inspections as needed.
• Drive process improvement and retirement of obsolete technologies.

Skills

Regulatory knowledge

GxP validation

LIMS experience

Validation leadership

Stakeholder management

Attention to detail

Project management

Education

Bachelor’s degree in computer science or life sciences

Tools

Veeva Quality

Provantis

Benchling

Elemental Machines

SoftMax Pro

MSD Discovery Workbench

QuantStudio

Analyst

Job description

Southern Research is seeking a Senior Validation Analyst to lead strategic validation efforts for GxP technologies. You will collaborate with Business, IT, and Quality teams to define requirements and deliver validation artifacts through the system lifecycle.

The role requires deep regulatory knowledge (GxP, Part 11, EU Annex 11) and the ability to manage multiple validation initiatives while ensuring systems stay in a validated state.