Principal Quality Architect for GxP Computer Systems

Grifols Shared Services North America, Inc; Clayton (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

Grifols Shared Services North America, Inc in Clayton, NC seeks Sr. Quality Associate I/II or Principal Quality Associate to support data integrity initiatives for GxP computer systems and provide QA oversight for validation in QC labs.

The role leads risk assessments, reviews access controls, and collaborates with system owners to ensure validated systems stay in control through change control and periodic reviews. Strong communication and independent work are essential.

Qualifications

• BS/BA degree preferably in a STEM discipline with minimum of 5 years relevant experience.
• Sr. Quality Associate II requires 6 years relevant experience; Principal requires 8+ years.
• Ability to train other employees and act as delegate to manager.
• Knowledge of 21 CFR Part 11 and EU Annex 11 is preferred.

Responsibilities

• Lead and support data integrity risk assessments, gap assessments, and remediation for GxP computer systems.
• Provide QA oversight for user access management, role-based security, audit trails, and e-records controls.
• Review and approve validation lifecycle docs including risk assessments, validation plans, tests, deviations, and reports.
• Collaborate with system owners to ensure validated systems remain in control through change control and periodic reviews.
• Serve as QA SME during regulatory inspections, audits, and CAPA activities for data integrity controls.
• Support FDA audits and regulatory commitments; assist with change control for manufacturing and lab systems.

Skills

Excellent communication

Independent work

Data integrity knowledge

Regulatory compliance

Education

BS/BA in STEM

Job description

Grifols Shared Services North America, Inc in Clayton, NC seeks Sr. Quality Associate I/II or Principal Quality Associate to support data integrity initiatives for GxP computer systems and provide QA oversight for validation in QC labs.

The role leads risk assessments, reviews access controls, and collaborates with system owners to ensure validated systems stay in control through change control and periodic reviews. Strong communication and independent work are essential.