QA Systems Manager

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 Quality Systems Manager 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 Quality Systems Manager is responsible for overseeing the execution and continuous improvement of Guerbet's Quality Management System (QMS). This role ensures compliance with global regulatory requirements (e.g., FDA, EMA, ANVISA, PIC/S), supports GMP operations, and drives a culture of quality across the organization. The manager will lead cross-functional initiatives to enhance documentation, training, change control, Data Integrity, Supplier Management, APQR management, Risk Management, Supplier Quality and audit readiness.

The incumbent will coach and develop their Direct Reports supporting the site's continuous improvement initiatives.

YOUR ROLE

Quality System Oversight

• Own, maintain, and continuously improve core Quality Management System (QMS) elements as defined in the role scope.
• Ensure QMS processes remain compliant, efficient, and aligned with current regulatory expectations (e.g., FDA, EU GMP).
• Lead periodic review and revision of SOPs, policies, and quality manuals to ensure accuracy and effectiveness.

Governance & Metrics

• Collaborate with
  
  Functional Area
  
  Leaders and Operational Excellence (OpEx) to define and monitor leading and lagging quality performance indicators.
• Analyze key performance indicators (KPIs) (e.g., change control cycle time) and drive continuous improvement actions.
• Present quality system performance metrics to senior leadership with recommendations for improvement.
• Chair or support Quality Governance forums, including Change Control Review Board meetings.

Audit & Inspection Readiness

• Lead preparation activities for internal audits and external regulatory inspections (FDA, EU, etc.).
• Oversee audit response processes, ensuring timely, thorough closure of observations and CAPAs.
• Maintain a continuous state of inspection readiness across the organization.

Cross-Functional Collaboration

• Partner with Manufacturing, Validation, Regulatory Affairs, R&D, and other stakeholders to ensure effective integration of quality systems.
• New product introductions (NPI)
• Technology transfers
• Process and system changes
• Performs other duties as assigned by management

Department Specific/Non
- Essential Functions:

• Support site-specific initiatives related to digital QMS tools or system implementations.
• Contribute to training program development for quality systems and compliance topics.
• Participate in or lead continuous improvement or Operational Excellence (OpEx) projects outside core QMS ownership.
• Provide support during regulatory submissions or inspections as a subject matter expert (SME), as needed.
• Assist…