Senior Quality Systems Specialist, GxP (Day Shift)

Grifols; North Carolina; On-site; USD 90,000 - 120,000; Full time

Job summary

Grifols seeks a Senior Quality Associate to oversee QA for GxP computerized systems across the lifecycle, including validation, data integrity governance, regulatory compliance, and lifecycle management. You will act as a technical QA expert for validated systems and ensure adherence to 21 CFR Part 11 and cybersecurity requirements.

The role involves partnering with system owners, supporting audits, inspections, and change controls, and driving risk-based decisions in a regulated environment.

Qualifications

• Excellent written and verbal communication in a regulated environment.
• Knowledge of domestic and international regulatory requirements.
• Ability to work independently and manage competing priorities.

Responsibilities

• Serve as Quality SME for validation and lifecycle management of GxP computerized systems.
• Collaborate with system owners to plan and complete validation deliverables.
• Maintain system inventory and required documentation for cGMP/CSI processes.
• Ensure systems meet data integrity, cybersecurity, and 21 CFR Part 11 requirements.
• Provide QA oversight of system administration, access reviews, and configuration.
• Define and verify backup, recovery, and business continuity activities.
• Support FDA inspections and regulatory commitments and readiness.
• Lead data integrity governance activities and MHRA/FDA alignment.
• Review Change Control requests for GxP systems and infrastructure.
• Provide timely QA input for validation projects and system enhancements.

Skills

Quality assurance

GxP regulation

Data integrity

Regulatory knowledge

Communication skills

Education

BA/BS in STEM

Job description

Grifols seeks a Senior Quality Associate to oversee QA for GxP computerized systems across the lifecycle, including validation, data integrity governance, regulatory compliance, and lifecycle management. You will act as a technical QA expert for validated systems and ensure adherence to 21 CFR Part 11 and cybersecurity requirements.

The role involves partnering with system owners, supporting audits, inspections, and change controls, and driving risk-based decisions in a regulated environment.