CSV Quality Lead - Validation Strategy & Compliance

CSI Companies; New Jersey; On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Voluntary life & AD&D coverage

Career advancement

Job summary

CSI Companies is seeking an experienced CSV Quality Support Lead to support Computer System Validation activities within a regulated environment. The role focuses on leading validation efforts across the system lifecycle while ensuring compliance with regulatory requirements and quality standards.

You will work closely with project teams, quality organizations, and business stakeholders to ensure validated systems are compliant and audit ready.

Qualifications

• Experience leading validation in regulated environments.
• Advanced knowledge of CSV methodologies and best practices.
• Experience applying risk based validation approaches.
• Experience developing and reviewing validation documentation.
• Experience creating and managing Requirements Traceability Matrices.
• Experience authoring and executing validation test scripts and protocols.
• Experience managing deviations and validation findings.
• Knowledge of GxP, data integrity, and compliance requirements.

Responsibilities

• Lead and execute CSV deliverables throughout the system lifecycle.
• Develop validation strategies utilizing risk based methodologies.
• Conduct system impact assessments and functional risk assessments.
• Define validation scope and testing approaches based on GxP impact and data integrity.
• Author and review validation documentation and compliance deliverables.
• Develop and maintain requirements traceability matrices.
• Create, review, and execute validation test scripts and protocols.
• Support deviation management and issue resolution.
• Prepare test summaries, validation reports, and compliance documentation.
• Ensure validation activities meet quality and regulatory requirements.
• Collaborate with business, quality, and technical teams.
• Support system releases and validation closeout.

Skills

CSV validation

Regulated environment leadership

Risk-based validation

Documentation writing

Testing & protocols

Deviation management

GxP knowledge

Stakeholder management

onsite collaboration

Tools

Requirements Traceability Matrix

Job description

CSI Companies is seeking an experienced CSV Quality Support Lead to support Computer System Validation activities within a regulated environment. The role focuses on leading validation efforts across the system lifecycle while ensuring compliance with regulatory requirements and quality standards.

You will work closely with project teams, quality organizations, and business stakeholders to ensure validated systems are compliant and audit ready.