QA Systems Specialist

At Guerbet, we build lasting relationships so that to enable people to live better
. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

Achieve
, Cooperate
, Care and Innovate are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

For more information on Guerbet, go to  and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

WHAT WE ARE LOOKING FOR

The QA Systems Specialist will be operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for. The QA Systems Specialist is responsible for supporting daily Quality Assurance activities to ensure compliance with cGMP requirements, regulatory standards, and company quality systems.

This role supports the maintenance and execution of quality systems and ensures the Raleigh site remains inspection ready at all times. The QA Systems Specialist collaborates with cross-functional teams, including Manufacturing, Quality Control, Supply Chain, Engineering, and Regulatory Affairs, to maintain product quality, compliance, and operational excellence. Operating in accordance with all safety, quality, and regulatory requirements, this position helps drive continuous

YOUR ROLE

• Promote and foster a culture of quality throughout the site by ensuring adherence to quality principles, regulatory requirements, and company standards.
• Partner with cross-functional teams and site leadership to support Quality Systems activities and drive compliance-focused decision-making.
• Collaborate with Global Regulatory Affairs to ensure site compliance with global product registrations.
• Ensure compliance with applicable FDA, cGMP, international regulatory requirements, and company quality systems.
• Review and assess quality-related documentation, including Change Controls, risk assessments, deviations, investigations, and records supporting changes to utilities, manufacturing, and Quality Control operations.
• Support management of the Change Control system through review and approval of change controls, KPI tracking, and system administration.
• Support Management Review meetings through data collection, analysis, and presentation of quality system metrics to site leadership.
• Compile and analyze Quality Systems data for Annual Product Reviews and other site quality reporting requirements.
• Provide Quality Assurance oversight and guidance for change controls and quality system activities.
• Identify, assess, elevate, and communicate quality risks, compliance concerns, and regulatory issues to site leadership in a timely manner.
• Support customer audits, regulatory inspections, and audit readiness activities by providing documentation, responses, and Quality Assurance expertise.

YOUR BACKGROUND

Required Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Engineering, or another scientific discipline.
• Minimum of 5 years of experience in the pharmaceutical, biotechnology, or other cGMP-regulated industry.
• Experience supporting Quality Systems, Quality Operations, Validation, Manufacturing Quality, or related…