Senior QA Lead — GxP Computerized Systems

Grifols Shared Services North America, Inc; Clayton (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Grifols is seeking a Senior Quality Associate in Clayton, NC to provide Quality Assurance oversight for GxP computerized systems across the lifecycle, including validation, data integrity governance, and regulatory compliance. You will partner with system owners and project teams to ensure validation deliverables are planned, reviewed, and completed.

Required: BA/BS in STEM and 4–6 years of relevant experience, with knowledge of FDA expectations, 21 CFR Part 11, and cGMP principles.

Qualifications

• BA/BS in STEM with 4-6 years of relevant experience.
• Minimum BA/BS degree required.
• Experience in validated GxP computerized systems preferred.
• Knowledge of FDA expectations and regulatory guidelines.

Responsibilities

• Serve as the Quality subject matter expert for validation and lifecycle management of GxP computerized systems.
• Partner with system owners, project teams, and business customers to ensure validation deliverables are planned, developed, reviewed, and completed across the lifecycle.
• Support cGMP/CSI processes by maintaining system inventory records and documentation.
• Provide Quality oversight to ensure systems are designed, configured, maintained, and validated per procedures, data integrity, cybersecurity, and regulatory expectations including 21 CFR Part 11.
• Provide independent QA oversight of system administration activities, including user access and change controls.
• Ensure backup, recovery, and business continuity requirements are defined, implemented, and tested.
• Support inspections, audits, and regulatory submissions related to computer system validation and Quality systems.
• Lead or support data integrity governance activities and align with MHRA, FDA, EU Annex 11/15 requirements.
• Review Change Control requests for GxP computerized systems.

Skills

Quality Assurance

GxP compliance

Data integrity

Regulatory knowledge

Documentation

Education

BA/BS in STEM

Job description

Grifols is seeking a Senior Quality Associate in Clayton, NC to provide Quality Assurance oversight for GxP computerized systems across the lifecycle, including validation, data integrity governance, and regulatory compliance. You will partner with system owners and project teams to ensure validation deliverables are planned, reviewed, and completed.

Required: BA/BS in STEM and 4–6 years of relevant experience, with knowledge of FDA expectations, 21 CFR Part 11, and cGMP principles.