CSV Lead: Regulatory IT Validation Expert

Cardiovascular Research Foundation; New York (NY); Hybrid; USD 110,000 - 130,000; Full time

Benefits offered by this job

Health plans including medical, dental, and vision

Company-paid disability and life insurance

401(k) plan

Generous paid time off (PTO)

Job summary

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.

Qualifications

• 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.

Responsibilities

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

Skills

Computer System Validation (CSV)

Technical writing

QA methodologies

Risk analysis

Education

Bachelor’s degree in a technical or scientific discipline

Job description

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.