Senior CSV/CSA Leader - GxP Validation & Compliance

Ladders; United States; Remote; USD 105,000 - 130,000; Full time

Benefits offered by this job

Remote work flexibility

Mentorship opportunities

Professional development

Cross-functional collaboration

Exposure to GxP systems

Job summary

Ladders is seeking a Senior Computer System Validation Specialist to lead validation strategy for GxP computerized systems in a highly regulated healthcare environment. You will partner with IT, Quality, and Compliance to ensure audit-ready systems and robust lifecycle documentation.

Remote role for US-based candidates, with mentorship responsibilities and opportunities to drive process improvements across validation activities and SDLC governance.

Qualifications

• Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or a related field.
• 5+ years of experience in CSV, CSA, IT quality, software validation, change control, SDLC, or GxP computerized systems.
• Strong knowledge of GxP regulations, including 21 CFR Part 11 and EU Annex 11.
• Proficiency in risk-based validation practices and validation lifecycle deliverables.
• Excellent technical writing and communication skills.
• Experience leading validation strategies for various systems.
• Ability to mentor junior team members and provide technical guidance.

Responsibilities

• Lead validation and assurance strategy for GxP systems throughout their lifecycle
• Author and review validation lifecycle deliverables ensuring compliance and readiness
• Provide IT Quality and Compliance oversight for computerized systems and SDLC activities
• Support system lifecycle activities including validation, change control, and periodic reviews
• Mentor and coach junior CSV/CSA team members and cross-functional project teams
• Identify compliance gaps and process improvement opportunities
• Facilitate cross-functional meetings related to validation strategy and audit readiness

Skills

CSV/CSA expertise

GxP validation

Regulatory compliance

Technical writing

Leadership & mentoring

Education

Bachelor’s degree in Computer Science or related field

Job description

Ladders is seeking a Senior Computer System Validation Specialist to lead validation strategy for GxP computerized systems in a highly regulated healthcare environment. You will partner with IT, Quality, and Compliance to ensure audit-ready systems and robust lifecycle documentation.

Remote role for US-based candidates, with mentorship responsibilities and opportunities to drive process improvements across validation activities and SDLC governance.