Senior GxP CSV QA Lead for Validation & Compliance

Real Staffing; United States; On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health insurance

Health savings accounts

Retirement savings plan

Life and disability insurance

Paid leave

Job summary

Specialist Staffing Group is seeking a QA professional to lead validation efforts for GxP computerized systems in the biopharmaceutical space. You will collaborate with IT and business owners to ensure risk-based validation across the system lifecycle.

The role requires extensive knowledge of FDA 21 CFR Part 11, EU Annex 11, ICH guidelines, and GAMP 5, with a focus on quality oversight and regulatory compliance. Strong communication and independent work capability are essential.

Qualifications

• Bachelor's degree in a scientific, engineering, computer science, or related discipline.
• 6+ years of relevant experience in the biopharmaceutical or pharmaceutical industry.
• Direct experience in GxP computerized system validation (CSV/CSA), risk-based validation methodologies and system lifecycle management.
• Solid knowledge of applicable regulatory requirements and industry best practices, including FDA CSA Guidance for Industry, 21 CFR Part 11, EU Annex 11, ICH guidelines, GAMP 5.
• Ability to work independently and collaboratively within a team with minimal direction.
• Excellent attention to detail and strong organizational and communication skills, both written and verbal.
• Previous QA Validation experience.

Responsibilities

• Lead and represent QA on cross-functional teams supporting implementation, validation, and maintenance of GxP computerized systems.
• Ensure compliance with company policies, procedures, and regulatory requirements governing computer system validation.
• Provide guidance and oversight on validation strategies, risk-based approaches, and compliance expectations throughout the computerized system lifecycle.
• Collaborate with business owners, system owners, and CSV personnel to support risk-based validation activities and resolve any compliance-related issues.
• Review and approve validation lifecycle documentation, including risk assessments, URS, FRS, CS, test protocols, and validation summary reports.
• Serve as the QA approver for IT-related change controls and associated validation activities.
• Execute and approve periodic reviews for GxP computerized systems.

Skills

CSV validation

GxP experience

Regulatory knowledge

Quality oversight

Documentation

Independent work

Education

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

Tools

Veeva

LabVantage

TraceLink

Oracle

Statistica

Job description

Specialist Staffing Group is seeking a QA professional to lead validation efforts for GxP computerized systems in the biopharmaceutical space. You will collaborate with IT and business owners to ensure risk-based validation across the system lifecycle.

The role requires extensive knowledge of FDA 21 CFR Part 11, EU Annex 11, ICH guidelines, and GAMP 5, with a focus on quality oversight and regulatory compliance. Strong communication and independent work capability are essential.