Senior QA & CSV Lead for GxP Compliance (Remote)

i-Pharm Consulting; New Jersey; Hybrid; USD 120,000 - 160,000; Full time

Job summary

i-Pharm Consulting seeks a Senior QA Specialist - CSV & GxP Quality Assurance to oversee QA for enterprise GxP systems across their lifecycle, ensuring validation and inspection readiness. You will partner with IT, Quality, Validation, and external vendors to maintain compliance.

The role focuses on platforms like ServiceNow, Qlik, and other regulated systems, ensuring adherence to FDA/EMA guidance and CSA requirements. Strong background in CSV and data integrity is essential.

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Engineering, Quality, or related discipline.
• Minimum 7 years of experience in FDA-regulated environments (Pharma/Biotech/Life Sciences).
• Strong CSV, GxP Compliance, QA, and Validation Lifecycle Management expertise.
• Hands-on knowledge of 21 CFR Part 11, EU Annex 11, FDA CSA, ISPE GAMP 5, and Data Integrity (ALCOA+).
• Experience supporting Change Controls, Deviations, CAPAs, and Audit Readiness.

Responsibilities

• Provide QA oversight for GxP computerized systems throughout implementation, operation, maintenance, enhancement, and retirement.
• Ensure systems remain validated and compliant with applicable regulations and industry standards.
• Act as the primary Quality representative for enterprise GxP systems including ServiceNow and Qlik.
• Review and approve validation lifecycle documentation (URS, FS, Validation Plans, IQ/OQ/PQ, Test Scripts, VSR).
• Participate in regulatory inspections, audits, and audit readiness activities.
• Support AI/ML validation governance and risk-based strategies.

Skills

CSV

GxP Compliance

Quality Assurance

Validation Lifecycle

21 CFR Part 11

EU Annex 11

FDA CSA

ISPE GAMP 5

Data Integrity ALCOA+

Audit Readiness

Change Controls

Deviations

CAPAs

Regulatory Inspections

AI/ML Validation Awareness

Education

Bachelor's degree in Life Sciences, Computer Science, Engineering, Quality, or related discipline

Tools

ServiceNow

Qlik

LIMS

CDS

ELN

Empower

EDC

CTMS

eTMF

Job description

i-Pharm Consulting seeks a Senior QA Specialist - CSV & GxP Quality Assurance to oversee QA for enterprise GxP systems across their lifecycle, ensuring validation and inspection readiness. You will partner with IT, Quality, Validation, and external vendors to maintain compliance.

The role focuses on platforms like ServiceNow, Qlik, and other regulated systems, ensuring adherence to FDA/EMA guidance and CSA requirements. Strong background in CSV and data integrity is essential.