What are the responsibilities and job description for the QA Systems Manager position at Guerbet?
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 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.
Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis.
Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging. 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
Required Qualifications
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 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.
Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis.
Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging. 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.
- 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.
- 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.
- Partner with Manufacturing, Validation, Regulatory Affairs, R&D, and other stakeholders to ensure effective integration of quality systems.
- Provide quality oversight for:
- New product introductions (NPI)
- Technology transfers
- Process and system changes
- Performs other duties as assigned by management
- 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 in benchmarking or industry best practice evaluations to enhance QMS maturity.
- Support additional departmental projects or cross-site initiatives as assigned.
- Performs other duties as assigned by management
Required Qualifications
- Bachelor’s degree in Life Sciences, Engineering, or related field
- 7 years of experience in pharmaceutical QA, with 3 years in quality systems leadership.
- Deep understanding of GMP regulations (21 CFR Parts 210/211, EU Annexes, ICH Q10).
- Proven experience managing audits and regulatory inspections.
- Strong analytical, organizational, and communication skills.
- Advanced degree (MS, MBA, or Ph.D.).
- Experience with electronic QMS platforms
- Six Sigma or Lean certification
- Experience in sterile manufacturing or biologics