QA Operations Sr. 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 that we 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.

The QA Operations Sr. 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 QA Operations Sr. Manager provides quality leadership and oversight across site operations, including materials, manufacturing, warehouse activities, quality interfaces, and product release. This role partners closely with cross‑functional leaders to ensure robust processes, effective risk management, and consistent delivery of compliant, high‑quality products. As a member of the Site Quality Leadership Team, the role drives a strong quality culture, supports continuous improvement, and translates regulatory expectations into practical, sustainable operational practices.

• Provide independent QA oversight and partnership across all operational activities, including incoming materials, warehouse, manufacturing, QC, and product disposition.
• Ensure operational processes are designed and executed in compliance with GMP, ALCOA+ data integrity principles, and internal quality standards.
• Partner with operational leaders to ensure processes are robust, capable of right‑first‑time execution, and support operational decision‑making.
• Ensure timely escalation of significant quality risks to site leadership and the Head of Quality.
• Apply quality risk management principles (ICH Q9) in all operational decision‑making.

• Act as a catalyst for a strong quality culture, providing guidance and coaching to operational teams.
• Ensure QA presence in operations through Manufacturing QA and other QA Operations teams.
• Translate regulatory expectations into practical, meaningful practices.
• Promote proactive identification of risks, operational issues, and improvement opportunities.
• Support teams in analyzing situations, addressing root causes, and implementing sustainable improvements.
• Drive continuous improvement initiatives to enhance process robustness and operational performance.

• Provide oversight for quality events impacting operations, including exceptions, non‑conformances, and OOS results.
• Drive timely, scientifically sound investigations focused on root cause and effective, sustainable corrective and preventive actions.
• Responsible appropriate escalation, communication, and closure of significant quality events.

• Oversee batch record review and product disposition processes.
• Ensure robust review processes support compliant and timely product release.
• Assess and address quality issues impacting batch disposition.

• Provide leadership for sterility assurance via the Sterility Assurance function.
• Ensure implementation, maintenance, and continuous improvement of the site Contamination Control Strategy (CCS).
• Oversee contamination control practices, aseptic manufacturing, environmental monitoring, and utilities microbiological risks.
• Ensure compliance with regulatory expectations and industry best practices for sterile product manufacturing.

• Lead QA‑driven projects and cross‑functional improvement initiatives.
• Promote…