Quality Systems Specialist - Pharma Compliance & QA

Guerbet; Raleigh (NC); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Personal development

Job summary

Guerbet seeks a QA Systems Specialist to ensure cGMP compliance and quality system integrity at the Raleigh site. You will partner with Manufacturing, Quality Control, Supply Chain, Engineering, and Regulatory Affairs to maintain inspection readiness and high-quality operations.

The role focuses on Change Controls, KPI tracking, data analysis, and management reviews, supporting audits and regulatory inspections while maintaining global quality standards and continuous improvement initiatives.

Qualifications

• Bachelor’s degree in a scientific discipline and 5+ years in a cGMP-regulated industry.
• Experience supporting Quality Systems, Quality Operations, Validation, or related quality functions.
• Experience with regulatory inspections, customer audits, and internal audit programs.
• Experience with Change Control processes as initiator, reviewer, or Quality approver.
• Knowledge of QA principles, quality systems, and regulatory compliance.

Responsibilities

• Promote and foster a culture of quality at the site; ensure regulatory compliance and company standards.
• Partner with cross-functional teams and site leadership to support Quality Systems and drive compliant decision-making.
• Collaborate with Global Regulatory Affairs to ensure site compliance with global registrations.
• Ensure compliance with FDA, cGMP, and international regulatory requirements and company quality systems.
• Review and assess quality documentation including Change Controls, deviations, investigations, and records.

Skills

QA Systems

Regulatory compliance

Cross-functional collaboration

Documentation control

Microsoft Office

Education

Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Engineering

Tools

eQMS software

Change Control systems

Regulatory databases

Job description

Guerbet seeks a QA Systems Specialist to ensure cGMP compliance and quality system integrity at the Raleigh site. You will partner with Manufacturing, Quality Control, Supply Chain, Engineering, and Regulatory Affairs to maintain inspection readiness and high-quality operations.

The role focuses on Change Controls, KPI tracking, data analysis, and management reviews, supporting audits and regulatory inspections while maintaining global quality standards and continuous improvement initiatives.