QA 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.

You can find more information on Guerbet at  and follow Guerbet on Linkedin, Twitter, Instagram and Youtube.

Guerbet is looking for a qualified, dynamic QA Manager to enhance our quality management system through comprehensive SOP development, review, and revision, ensuring compliance with FDA regulations including CFR (Code of Federal Regulations), ISO standards, industry best practices, as well as all applicable legislative requirements for the company’s product portfolio.

Working with cross-functional teams, you will be an excellent communicator and will be responsible for ensuring that all projects have the appropriate local quality and safety input and guidance.

Implementation and maintenance of an audit and quality assurance system at the local level aligned with the Policies of the Group.

General

• Ensure good relations and communications with all members of the team and responding respectfully and in a timely fashion to internal and external customers.
• Interact influentially with all members of staff to maintain and develop a positive progressive Quality culture throughout the organization.
• Perform other duties as assigned by management.

Quality Assurance

• Ensure compliance with the legislative requirements as set out by FDA (21 CFR 314, 21 CFR 820, 21 CFR 822) and PIC/S PE 011-1, as well as all applicable legislative requirements for the company’s product portfolio.
• Ensure that all third‑party contractors are legally approved, and the applicable Technical Quality Agreements (TQA) are in place.
• Prepare and act as signatory in quality agreements (intercompany and external).
• Ensure the implementation of ISO 13485:2016 requirements for a quality management system where the organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
• Ensure the business complies with cGxP requirements.
• Be able to retrieve product traceability and ensure recall readiness.
• Responsible to attend and support regulatory body inspections (For example‑FDA, state agencies or any other health authority) at Guerbet LLC level.
• Ensure the conformity of fully finished imported pharmaceutical product and release for the US market.
• Perform the Product Quality Review system by reviewing PQRs and engaging with relevant departments to address recommendations and outstanding information.
• Oversee the Customer Complaints system and facilitate investigations to establish root cause and work with cross functional teams to facilitate the resolution of the customer complaints.
• Administration and monitor the QMS, including SOPs, quality management meetings, change controls, deviations, quality risk assessments, customer complaints, recalls, adulteration or counterfeiting investigations, periodic reviews, self‑inspection and external audit reports.
• Facilitate follow‑up meetings to discuss the audit findings, clarify questions, and agree on timelines for implementing the corrective action plans.
• Ensure any updates and reviews of SOPs are documented and stored in a controlled system and ensure compliance with Global SOPs and with regulatory standards across various operations within the organization.
• Cooperate with Training Responsible to ensure the appropriate training of the staff.
• Provide quality support for assistance with…