Senior CSV Lead — GxP Validation & Divestiture Expert

Katalyst CRO; Raritan (NJ); On-site; USD 110,000 - 170,000; Full time

Job summary

Katalyst CRO in New Jersey seeks an experienced CSV/Validation leader to guide end-to-end Computer System Validation in GxP environments. You will oversee risk-based strategies, review validation documents, and ensure regulatory compliance across global teams.

You will mentor validation professionals, coordinate ERP and data migration efforts, and drive clean, audit-ready deliverables in complex pharmaceutical, biotech, and medical device programs.

Qualifications

• Extensive experience in CSV / Validation within regulated environments.
• Proven track record in FDA/GxP compliance.
• Experience with risk-based validation strategies.
• Leadership of validation teams across global / remote groups.
• ERP, data migration, and cloud migration experience.

Responsibilities

• Lead end-to-end CSV activities (inventory, assessment, remediation, disposition).
• Define and implement risk-based validation strategies.
• Review and approve test plans, UAT scripts, validation documents.
• Ensure compliance with regulatory and quality standards.
• Provide guidance, escalation and leadership to validation teams.
• Collaborate with global and remote teams.

Skills

CSV Validation

GxP Compliance

Risk-Based Validation

Regulatory Documentation

Leadership

Job description

Katalyst CRO in New Jersey seeks an experienced CSV/Validation leader to guide end-to-end Computer System Validation in GxP environments. You will oversee risk-based strategies, review validation documents, and ensure regulatory compliance across global teams.

You will mentor validation professionals, coordinate ERP and data migration efforts, and drive clean, audit-ready deliverables in complex pharmaceutical, biotech, and medical device programs.