Senior Digital Systems QA/CSV – GxP & AI/ML Validation

Ameri-partners; New Jersey; On-site; USD 110,000 - 180,000; Full time

Job summary

Ameri Partners is seeking a Senior Associate – Digital Systems QA / CSV to provide GxP quality oversight and validation support for enterprise, clinical, laboratory, and AI/ML-enabled applications. This role emphasizes risk-based validation, regulatory compliance, data integrity, and maintaining validated systems throughout their lifecycle.

Collaboration across IT, Quality, and business stakeholders is essential.

Qualifications

• Bachelor's degree in Life Sciences, CS, Engineering, or related field.
• 7+ years of GxP CSV experience in pharma/biotech.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, and risk-based validation.
• Experience with AI/ML system validation or GxP quality oversight.
• Familiarity with FDA CSA guidance and EU Annex 22.

Responsibilities

• Develop, review, and approve CSV docs (Validation Plans, URS, IQ/OQ/PQ, RTMs, Summary Reports).
• Execute validation protocols, review evidence, manage discrepancies.
• Provide GxP quality oversight for Veeva Vault, ServiceNow, LIMS, and clinical systems.
• Apply risk-based validation and CSA principles.
• Support change controls, regression testing, revalidation, and periodic reviews.
• Assess 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity.
• Validate AI/ML-GxP apps incl testing and change control.
• Conduct supplier assessments and vendor qualification documentation.
• Support SOPs, CAPA, internal audits, and inspection readiness.
• Collaborate with IT, Quality, system owners, and stakeholders.

Skills

GxP CSV

Regulatory knowledge

Technical writing

Communication

Problem solving

Risk-based validation

AI/ML validation

Education

Bachelor's degree

Tools

Veeva Vault

ServiceNow

LIMS

Qlik

Microsoft Entra ID

Job description

Ameri Partners is seeking a Senior Associate – Digital Systems QA / CSV to provide GxP quality oversight and validation support for enterprise, clinical, laboratory, and AI/ML-enabled applications. This role emphasizes risk-based validation, regulatory compliance, data integrity, and maintaining validated systems throughout their lifecycle.

Collaboration across IT, Quality, and business stakeholders is essential.