CSV Lead: Regulatory IT Validation Expert

Cardiovascular Research Foundation; New York (NY); Híbrido; USD 110.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health plans including medical, dental, and vision

Company-paid disability and life insurance

401(k) plan

Generous paid time off (PTO)

Descripción de la vacante

The Cardiovascular Research Foundation in New York is hiring a Systems Validation Lead for a hybrid role overseeing validation lifecycles of critical clinical research applications. This position acts as a key liaison between IT and Quality Assurance, ensuring compliance with regulatory standards.

The ideal candidate has a Bachelor's degree and at least 6 years of CSV experience, along with strong technical writing and documentation skills. The position offers comprehensive health benefits and a salary range of $110,000 to $130,000 annually.

Formación

• Minimum 6 years of direct CSV experience in a GxP-regulated environment.
• Expertise in IQ, OQ, PQ methodologies and documentation.
• Knowledge of global regulatory requirements and industry practices.

Responsabilidades

• Oversee validation lifecycle for GxP-regulated applications.
• Lead risk assessments and define validation scope.
• Act as liaison between IT and QA for project support.

Conocimientos

Computer System Validation (CSV)

Technical writing

QA methodologies

Risk analysis

Educación

Bachelor’s degree in a technical or scientific discipline

Descripción del empleo

The Cardiovascular Research Foundation in New York is hiring a Systems Validation Lead for a hybrid role overseeing validation lifecycles of critical clinical research applications. This position acts as a key liaison between IT and Quality Assurance, ensuring compliance with regulatory standards.

The ideal candidate has a Bachelor's degree and at least 6 years of CSV experience, along with strong technical writing and documentation skills. The position offers comprehensive health benefits and a salary range of $110,000 to $130,000 annually.