Non-IT Project Management - Associate-Senior-C

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

Senior QA Specialist - Computer Systems Validation (CSV) & GxP Quality Assurance

Location: Remote / Hybrid

Employment Type: Contract / Permanent

Industry: Pharmaceutical / Biotechnology / Life Sciences

About the Role

We are seeking an experienced Senior QA Specialist - Computer Systems Validation (CSV) to provide Quality Assurance oversight for GxP computerized systems across their full lifecycle. This role will partner closely with IT, Quality, Validation, Business Process Owners, and external vendors to ensure computerized systems remain compliant, validated, and inspection-ready in support of patient safety, product quality, and regulatory compliance.

The successful candidate will act as a key Quality representative for enterprise GxP platforms including Veeva Vault, ServiceNow, Qlik, Entra ID, and other regulated systems, ensuring compliance with FDA, EMA, ICH, GAMP 5, and Computer Software Assurance (CSA) requirements.

Key Responsibilities

Quality & Compliance Oversight

• Provide QA oversight for GxP computerized systems throughout implementation, operation, maintenance, enhancement, and retirement.
• Ensure systems remain in a validated state and compliant with applicable regulations and industry standards.
• Act as the primary Quality representative for enterprise GxP systems, including:
• ServiceNow
• Qlik

Computer Systems Validation (CSV)

• Review and approve validation lifecycle documentation including:
• User Requirement Specifications (URS)
• Functional Specifications (FS)
• Validation Plans
• IQ/OQ/PQ Protocols
• Test Scripts
• Validation Summary Reports
• Apply risk-based validation strategies using:
• FDA Computer Software Assurance (CSA)
• ISPE GAMP 5
• Data Integrity principles
• Support validation activities for:
• SaaS platforms
• Cloud-hosted systems

Quality Systems Support

• Review and approve:
• Change Controls
• Deviations
• CAPAs
• Periodic Reviews
• Supplier Quality documentation
• Drive continuous compliance and quality improvements across computerized systems.

Regulatory & Inspection Readiness

• Ensure compliance with:
• 21 CFR Part 11
• EU Annex 11
• FDA Guidance
• ICH Guidelines
• GAMP 5
• Participate in regulatory inspections, audits, and audit readiness activities.
• Support supplier qualification and vendor audits.

Data Integrity & Risk Management

• Assess system changes and enhancements for:
• Patient safety impact
• Product quality risk
• Data integrity implications
• Ensure compliance with ALCOA+ principles.
• Support implementation of risk-based validation approaches aligned with business needs.

AI & Emerging Technologies

• Support validation and quality oversight for AI/ML-enabled solutions.
• Evaluate AI-enabled systems using risk-based approaches aligned with current industry guidance and GAMP AI frameworks.
• Collaborate with stakeholders on governance and compliance for emerging technologies.

Required Skills & Experience

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

Preferred Systems Experience

Experience with one or more of the following:

• ServiceNow
• Qlik
• Clinical Systems (EDC, CTMS, eTMF, IRT)
• Laboratory Systems (LIMS, CDS, ELN, Empower)

Preferred Qualifications

• ASQ Certifications:
• CSQE
• CQE
• CQA
• Experience supporting SaaS and cloud-based GxP platforms.
• Experience supporting AI/ML platform validation.
• Regulatory inspection support experience.
• Strong stakeholder management and communication skills.