Quality Systems Improvement 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 www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

WHAT WE ARE LOOKING FOR

The Quality Systems Improvement 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.

This role focuses on strengthening and improving the Quality Management System (QMS) by translating regulatory requirements, internal assessments, and operational insights into practical, sustainable enhancements. Working cross-functionally with Quality, Operations, and other stakeholders, the Specialist ensures quality systems are robust, compliant, and effectively embedded across the organization. It is a hands-on position dedicated to implementing improvements and driving long-term quality system effectiveness rather than providing oversight alone. THIS ROLE IS A CONTRACT ROLE THAT WILL LAST 18-24 MONTHS AND WILL BE ELIGIBLE FOR GUERBET BENEFITS.

YOUR ROLE

• Lead and actively contribute to the implementation of CAPAs and quality system improvements originating from internal assessments and evaluations.
• Translate regulatory expectations and quality commitments into clear, practical actions across the organization.
• Work with cross-functional teams to ensure corrective and preventive actions are fully implemented and embedded into routine processes and governance structures.
• Monitor progress of improvement initiatives, identify barriers, and facilitate resolution with relevant stakeholders.
• Verify effectiveness of implemented actions through structured follow-up, data analysis, and objective evidence.
• Contribute to the continuous improvement and integration of core QMS elements, including change control, deviations, CAPA management, internal audits, and document management systems.
• Collaborate with stakeholders to ensure QMS processes remain robust, practical, and aligned with regulatory expectations and company policies.
• Support the development and maintenance of governance structures that enable accountability, effective decision-making, and sustainable compliance.
• Performs other duties as assigned by management

YOUR BACKGROUND

Required Qualifications

• Bachelor’s degree in Life Sciences, Quality, Engineering, or a related field (or equivalent combination of education and experience).
• 10+ years of experience in pharmaceutical Quality Assurance, Quality Systems, or Quality Compliance within a GMP-regulated environment.
• Demonstrated experience contributing to Quality Management System (QMS) improvements or transformation initiatives.
• Strong expertise in root cause analysis, CAPA systems, and quality governance frameworks.
• Solid understanding of 21 CFR Parts 210 and 211 and general GMP regulatory expectations.
• Practical experience applying Quality Risk Management (ICH Q9) principles and risk-based decision-making.

Preferred Qualifications

• Experience working in sterile manufacturing or terminal sterilization environments.
• Knowledge of global regulatory expectations for sterile products (e.g., FDA, EMA, PIC/S).
• Experience supporting regulatory inspections, audit readiness, or quality system remediation efforts.

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 careers@guerbet.com or you can also call this number +19843443717