GxP Systems Validation Lead – CSV & QA Compliance

Cardiovascular Research Foundation; Village of Great Neck (NY); Hybrid; USD 110,000 - 130,000; Full time

Benefits offered by this job

Health plans

Disability coverage

401(k) plan

PTO

Paid holidays

Job summary

The Cardiovascular Research Foundation seeks a Systems Validation Lead to oversee the validation lifecycle for GxP-regulated applications used in clinical research. You will coordinate between IT and QA and focus on medical imaging workstations and clinical data systems to ensure compliance and quality.

As the SME for CSV, you will develop validation strategies, execute protocols (IQ/OQ/PQ), and maintain traceability while supporting FDA/EMA inspections and vendor reviews.

Qualifications

• 6+ years direct CSV experience in a GxP-regulated environment.
• Deep knowledge of IQ, OQ, PQ methodologies and validation lifecycle.
• Strong regulatory knowledge including 21 CFR Part 11 and GAMP 5.

Responsibilities

• Lead validation strategy and risk assessment for new/existing systems.
• Author, review, and approve validation documents (VPs, VSRs).
• Serve as SME for CSV and interface between IT, QA, and project teams.

Skills

CSV validation

IQ/OQ/PQ

Regulatory knowledge

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in CS/Engineering/Biology

Job description

The Cardiovascular Research Foundation seeks a Systems Validation Lead to oversee the validation lifecycle for GxP-regulated applications used in clinical research. You will coordinate between IT and QA and focus on medical imaging workstations and clinical data systems to ensure compliance and quality.

As the SME for CSV, you will develop validation strategies, execute protocols (IQ/OQ/PQ), and maintain traceability while supporting FDA/EMA inspections and vendor reviews.