Senior QA Lead — CSV & Validation Expert

Johnson & Johnson Co.; Wilson (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Johnson & Johnson is seeking a Quality professional to lead CSV validation and quality assurance activities at a Wilson, NC site. The role focuses on ensuring data integrity, regulatory compliance, and validated systems across manufacturing and laboratory environments.

The ideal candidate has 6+ years in pharma/biotech quality with hands-on experience in CSV, 21 CFR Part 11, GAMP 5, and risk-based testing. Knowledge of SDLC and supplier oversight is a plus, with strong technical writing skills.

Qualifications

• Bachelor's degree in scientific/engineering/computer science field.
• 6+ years in pharma/biotech with CSV/QA experience.
• Hands-on CSV validation for automated systems and GMP labs.

Responsibilities

• Author, implement, and maintain site CSV and data integrity procedures.
• Provide QA oversight on qualification activities across requirements, design review, construction, commissioning, and validation to ensure quality and data integrity.
• Apply GAMP 5, ICH Q9, and ASTM E2500 principles to risk-based validation and testing.
• Review and approve URS, FRS, HDS, SDS, IQ, OQ, PQ, and validation artefacts as needed.

Skills

Quality Assurance

CSV validation

GxP compliance

Data integrity

Risk-based thinking

Education

Bachelor's degree in a scientific, engineering, or computer science discipline

Tools

Kneat

ValGenesis

SDLC

LIMS/ERP

Job description

Johnson & Johnson is seeking a Quality professional to lead CSV validation and quality assurance activities at a Wilson, NC site. The role focuses on ensuring data integrity, regulatory compliance, and validated systems across manufacturing and laboratory environments.

The ideal candidate has 6+ years in pharma/biotech quality with hands-on experience in CSV, 21 CFR Part 11, GAMP 5, and risk-based testing. Knowledge of SDLC and supplier oversight is a plus, with strong technical writing skills.