Cardiovascular Research Foundation · 14 hours ago
Systems Validation Lead
New York, NY
Full-time
Hybrid
Mid, Senior Level
$110K/yr - $130K/yr
6+ years expCardiovascular Research Foundation is focused on enhancing and saving patient lives, and they are seeking a Systems Validation Lead to oversee the validation lifecycle for GxP-regulated applications in clinical research. This role will act as a liaison between IT and Quality Assurance and will involve developing validation strategies, leading execution activities, and ensuring compliance with regulatory standards.
Health Care
Responsibilities
Lead risk assessments (e.g., GAMP 5) to define validation scope and testing rigor for new and existing systems
Author, review, and approve critical validation lifecycle documents, including Validation Plans (VP) and Validation Summary Reports (VSR)
Serve as the primary validation SME for internal teams and during regulatory authority inspections (including but not limited to US Food and Drug Administration (FDA), European Medicines Agency (EMA), other applicable jurisdictional authority) and audits of the Foundation
Lead the hands-on authoring, review, and execution of comprehensive validation test protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
Collaborate with business owners, IT, QA, and functional teams to define and document User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and other specifications as applicable
Develop and maintain a Traceability Matrix for each system to ensure all requirements are tested, verified, and thoroughly documented, including maintenance of traceability documentation for version or device upgrades
Oversee the resolution of all validation deviations, supporting Foundation QA in documenting investigations and ensuring appropriate corrective actions are implemented
Interview Foundation staff as needed to gather and document system validation requirements
Act as the primary liaison between IT project teams and the Quality Assurance department, ensuring validation activities align with technical goals, compliance mandates, and project-specific regulatory expectations
Manage the change control process for validated systems, performing impact analyses to determine necessary re-validation, regression testing, or additional testing activities
Provide expert guidance on 21 CFR Part 11 and Annex 11 requirements, pertaining to the Foundation’s use of electronic records, electronic signatures, and system audit trails
Support QA in partnering with vendors to review their validation packages and ensure their systems meet Foundation standards
Assist in drafting or updating Foundation procedures and policies related to the implementation and use of systems
Qualification
Required
Bachelor's degree in a technical or scientific discipline (e.g., Computer Science, Engineering, Biology)
A minimum of 6 years of direct experience in Computer System Validation (CSV) within a GxP-regulated environment (e.g., healthcare, pharmaceutical, biotechnology, or medical device)
Expert-level knowledge and proven, hands-on application of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) methodologies
Deep understanding of global regulatory requirements and industry best practices, including US 21 CFR Part 11, GAMP 5, and requirements of other applicable jurisdictional regulations
Demonstrated experience authoring the full suite of validation documentation (VP, URS, FRS, IQ/OQ/PQ Protocols & Reports, Traceability Matrix, VSR, objective evidence of testing)
Exceptional technical writing skills with a high degree of accuracy and attention to detail
Proven ability to work effectively in a matrixed organization, balancing the needs of technical and quality stakeholders
Preferred
Experience in a lead or project management role for validation projects
Familiarity with software development lifecycle (SDLC) methodologies
Experience participating in or leading vendor/customer audits
Professional certifications (e.g., CQA, CSQE) are a plus
Benefits
Choice of health plans include medical, Dental, and vision coverage
Company-paid short-term and long-term disability and life insurance
Health and dependent care flexible spending accounts
Pre-tax travel expenses through TransitChek program
401(k) plan
Generous paid time off (PTO)
Ten paid holidays each year
Company
Cardiovascular Research Foundation
The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving.
51-200 employees
H1B Sponsorship
Cardiovascular Research Foundation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (3)
2023 (3)
2022 (1)
2021 (1)
2020 (5)
Funding
Current Stage
Growth StageLeadership Team
Donald L. Abrams
Chief Legal Officer
Shawn Ricketts, SHRM-CP
Talent & Engagement Partner
Recent News
2025-11-08
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