Senior GxP CSV & QA Lead – Digital Systems

Madison-Davis, LLC; Bridgewater Township (NJ); Híbrido; USD 140.000 - 190.000; Jornada completa

Descripción de la vacante

Madison-Davis, LLC seeks a Senior Engineer, Digital Systems Quality Assurance to oversee compliance and validation of enterprise computerized systems in a GxP environment.

You will provide hands-on validation expertise across lifecycle stages and support QA oversight of changes, upgrades, and migrations, working with IT, QA, and business owners to ensure systems remain inspection-ready.

Formación

• Hands-on GxP computer system validation experience.
• Strong knowledge of validation documentation, testing, and traceability.
• Experience across multiple stages of the system lifecycle.
• Excellent collaboration with IT, QA and business system owners.

Responsabilidades

• Lead or support end-to-end computerized system validation, including planning, requirements, risk assessments, qualification protocols, testing, and reporting.
• Apply risk-based validation approaches aligned with FDA/EU expectations.
• Review, author, and approve validation deliverables and QA documentation.
• Provide QA oversight for system implementations, upgrades, data migrations, and change controls.
• Conduct periodic reviews and audit-trail assessments, user-access reviews, and related compliance activities.
• Collaborate with stakeholders on compliant validation for emerging digital systems.

Conocimientos

GxP Validation

Regulatory compliance

Lifecycle management

Cross-functional collaboration

Educación

Bachelor’s degree in science/engineering

Herramientas

Veeva Vault

ServiceNow GxP

Descripción del empleo

Madison-Davis, LLC seeks a Senior Engineer, Digital Systems Quality Assurance to oversee compliance and validation of enterprise computerized systems in a GxP environment.

You will provide hands-on validation expertise across lifecycle stages and support QA oversight of changes, upgrades, and migrations, working with IT, QA, and business owners to ensure systems remain inspection-ready.