Digital Systems Quality Assurance / CSV

Ameri-partners; New Jersey; In loco; USD 110.000 - 180.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

GxP CSV

Regulatory knowledge

Technical writing

Communication

Problem solving

Risk-based validation

AI/ML validation

Formazione

Bachelor's degree

Strumenti

Veeva Vault

ServiceNow

LIMS

Qlik

Microsoft Entra ID

Descrizione del lavoro

Ameri Partners is seeking an experienced Senior Associate – Digital Systems QA / CSV to provide GxP quality oversight and computerized system validation support for enterprise, clinical, laboratory, and AI/ML-enabled applications.

This role focuses on risk-based validation, regulatory compliance, data integrity, and maintaining validated systems throughout their lifecycle.

Key Responsibilities

• Develop, review, and approve CSV documentation, including Validation Plans, URS, IQ/OQ/PQ, RTMs, and Validation Summary Reports, within assigned authority.
• Execute validation protocols, review test evidence, and manage discrepancies and deviations.
• Provide GxP quality oversight for Veeva Vault, ServiceNow, LIMS, clinical platforms, and other computerized systems.
• Apply risk-based validation and Computer Software Assurance (CSA) principles.
• Support system change controls, regression testing, revalidation, and periodic reviews.
• Assess 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity controls.
• Support validation of AI/ML-enabled GxP applications, including testing, performance monitoring, human oversight, and change control.
• Conduct supplier assessments and review vendor qualification documentation.
• Support SOPs, CAPA, internal audits, and regulatory inspection readiness.
• Collaborate with IT, Quality, system owners, and business stakeholders.

Required Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related field.
• 7+ years of GxP CSV experience in pharmaceutical or biotechnology environments.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, and risk-based validation.
• Hands-on experience with validation lifecycle documentation, protocol execution, change control, and supplier qualification.
• Experience with AI/ML system validation or GxP quality oversight.
• Familiarity with FDA CSA guidance and emerging AI/ML regulatory expectations, including draft EU GMP Annex 22.
• Strong technical writing, communication, and problem-solving skills.

Preferred Experience

• Experience with Veeva Vault, ServiceNow, Qlik, Microsoft Entra ID, or LIMS.
• Exposure to clinical systems, QC laboratory applications, and cloud-based or SaaS platforms.