Senior GxP CSV Quality Lead

Real; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Real is seeking an experienced QA professional to lead the validation and control of GxP computerized systems in line with FDA/EU regulations. You will guide CSV strategies and partner with IT to ensure lifecycle compliance across enterprise applications supporting GxP operations.

You will review validation artifacts, provide risk-based oversight, and act as the QA approver for change controls. Strong documentation and communication skills are essential.

Qualifications

• Experience with GxP computerized systems and validation lifecycle.
• Knowledge of FDA 21 CFR Part 11, EU Annex 11, ICH guidelines.
• Ability to lead CSV/CSA activities and risk-based validation.
• Strong attention to detail and regulatory documentation.
• Experience coordinating with IT and cross-functional teams.

Responsibilities

• Lead QA on cross-functional teams for implementation, validation, and maintenance of GxP systems.
• Ensure compliance with company policies, procedures, and regulatory requirements for validation.
• Provide guidance on validation strategies, risk-based approaches, and lifecycle expectations.
• Collaborate with business owners and CSV personnel to support validation activities.
• Review and approve validation docs including risk assessments and validation summaries.
• Serve as QA approver for IT change controls and related validation activities.
• Execute and approve periodic reviews for GxP systems.

Skills

GxP knowledge

CSV validation

Regulatory guidance

Independent worker

Communication skills

Education

Bachelor's degree in science/engineering/CS

Tools

Veeva

Oracle

LabVantage

TraceLink

GAMP5

Job description

Real is seeking an experienced QA professional to lead the validation and control of GxP computerized systems in line with FDA/EU regulations. You will guide CSV strategies and partner with IT to ensure lifecycle compliance across enterprise applications supporting GxP operations.

You will review validation artifacts, provide risk-based oversight, and act as the QA approver for change controls. Strong documentation and communication skills are essential.