QA Systems Specialist

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

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 www.guerbet.com 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 quality functions.
• Experience participating in regulatory inspections, customer audits, and internal audit programs.
• Experience with Change Control processes as an initiator, reviewer, or Quality approver.
• Demonstrated knowledge of Quality Assurance principles, quality systems, and regulatory compliance within a regulated environment.
• Strong written, verbal, and interpersonal communication skills with the ability to collaborate effectively across functional areas.
• Strong organizational, analytical, problem-solving, and decision-making skills.
• Proficiency in Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint.

Preferred Qualifications

• Working knowledge of cGMP requirements and FDA and international regulatory expectations.
• Experience with electronic Quality Management Systems (eQMS), including management of deviations, CAPAs, change controls, document control, and training records.
• Experience supporting capital projects, facility expansions, equipment qualification, validation, or process implementation activities within a regulated environment.
• Experience administering or managing Change Control systems.
• Knowledge of risk management principles, quality improvement methodologies, and quality risk assessment tools.
• Familiarity with data integrity requirements and electronic record regulations, including 21 CFR Part 11.
• Experience supporting Annual Product Reviews (APRs), Management Review processes, or site quality metrics reporting.
• ASQ, RAPS, or other relevant quality-related certifications preferred.

Reason to join US

Much more than a Competitive salary,

We offer continued personal development. When you join Guerbet, you :

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
• Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
• Are joining a company where we value diversity of talents coming from various horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet.

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to [e-mail] or you can also call this number+19843443717