Senior QA Lead — GxP Computerized Systems

Grifols, S.A; Clayton (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Grifols, S.A in Clayton, NC is seeking a Senior Quality Associate I/II to provide QA oversight of GxP computerized systems throughout their lifecycle, including validation, data integrity governance, regulatory compliance, and system administration oversight.

You will collaborate with system owners and project teams to ensure validation deliverables, support FDA inspections, manage access controls, and lead data integrity governance and change control activities.

Qualifications

• QA oversight of GxP computerized systems across system lifecycle.
• Experience with validation, data integrity governance, and regulatory expectations (21 CFR Part 11).
• Ability to work with cross-functional teams and support inspections.

Responsibilities

• Serve as QA subject matter expert for validation and lifecycle management of GxP systems.
• Collaborate with system owners to plan, develop, review, and complete validation deliverables.
• Support cGMP/CSI processes with accurate records and documentation.
• Provide independent QA oversight of administration activities, access management, and risk-based decisions.

Skills

Quality Assurance

Regulatory compliance

Validation

GxP systems

Data integrity

Education

BA/BS in STEM

Job description

Grifols, S.A in Clayton, NC is seeking a Senior Quality Associate I/II to provide QA oversight of GxP computerized systems throughout their lifecycle, including validation, data integrity governance, regulatory compliance, and system administration oversight.

You will collaborate with system owners and project teams to ensure validation deliverables, support FDA inspections, manage access controls, and lead data integrity governance and change control activities.