Investigations Manager

About the role

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.

Responsibilities

• Provide hands-on leadership as a working manager, directly overseeing quality teams responsible for deviation/exception investigations, customer complaint investigations, CAPA management, and remediation activities.
• Serve as the site expert and authority on investigation practices, quality systems, and regulatory compliance, providing strategic direction and technical guidance to cross-functional stakeholders.
• Lead and support site quality improvement initiatives and cross-functional projects focused on compliance, operational excellence, and continuous improvement.
• Manage and develop multi-level quality teams supporting formulation, filling, and packaging operations; establish performance goals, conduct reviews, and actively mentor and develop staff.
• Maintain working knowledge of core and adjacent quality systems to provide backup support as needed, including Document Control, Change Control, Validation, Audits, Labeling, Training, and Site Inspection/Remediation Programs.
• Ensure robust data integrity oversight, including data review, investigation coordination, and assignment and completion of corrective and preventive actions.
• Proactively identify quality and compliance risks and, in partnership with the Site Quality Manager, recommend and drive effective corrective and preventive actions.
• Maintain compliance with applicable cGMP/GxP regulations and global regulatory standards, including FDA, ICH, EU, 21 CFR Part 11, and other applicable health authority requirements.
• Evaluate and improve systems, processes, metrics, and tools to enhance investigation quality, compliance performance, and operational efficiency, including the application of Lean and continuous improvement methodologies.
• Develop, review, approve, and support quality documentation, including SOPs, investigations, reports, validation protocols, change requests, risk assessments, and technical and laboratory documentation.
• Apply a strong working knowledge of quality, laboratory, manufacturing, validation, facilities, utilities, and sterile manufacturing processes (aseptic and terminal sterilization).
• Develop and deliver training and presentations to individuals and groups to ensure effective understanding and execution of quality and compliance expectations.
• Track, analyze, and report investigation, CAPA, and compliance metrics; present results and trends during Quality Management Review (QMR) meetings.
• Demonstrate sound judgment, professionalism, and the ability to make timely, data-driven decisions in a fast-paced manufacturing environment while supporting broader Guerbet Quality Plan and departmental goals.
• Ensure ongoing inspection readiness and support regulatory inspections, internal audits, and vendor aud