WHAT WE ARE LOOKING FOR

Guerbet is seeking an experienced and highly collaborative Quality Assurance Manager to support and strengthen our Quality Management System and ensure continued compliance across our pharmaceutical and medical device portfolio.

In this role, you will provide quality leadership across the organization, with responsibility for QMS oversight, SOP development, regulatory compliance, audits and inspections, CAPA, product quality activities, customer complaints, quality agreements, and third-party quality oversight.

You will work closely with cross-functional and global teams to ensure local operations meet applicable FDA requirements, cGxP standards, ISO 13485, PIC/S requirements, and Guerbet global quality policies. The ideal candidate brings strong technical QA expertise, sound judgment, and the ability to influence stakeholders while fostering a proactive culture of quality and continuous improvement.

YOUR ROLE

Quality Management & Compliance

• Maintain and continuously improve the local Quality Management System (QMS) in alignment with Guerbet global quality policies and applicable regulatory requirements.
• Ensure compliance with applicable requirements, including FDA regulations, 21 CFR 314, 21 CFR 820, 21 CFR 822, ISO 13485:2016, PIC/S PE 011-1, and cGxP standards.
• Oversee the development, review, approval, revision, and controlled management of SOPs and other quality documentation.
• Administer and monitor key QMS processes, including change controls, deviations, quality risk assessments, CAPAs, customer complaints, recalls, periodic reviews, self-inspections, and audit findings.
• Promote a strong quality culture by providing guidance and partnering effectively with teams across the organization.
• Collaborate with training stakeholders to ensure employees receive appropriate quality and compliance training.

Audits, Inspections & CAPA

• Support and participate in inspections conducted by the FDA, state agencies, and other applicable health authorities.
• Conduct or support internal self-inspections and audits and prepare appropriate audit responses.
• Coordinate and monitor CAPAs resulting from audits, inspections, deviations, and other quality events through effective implementation and closure.
• Analyze audit and inspection findings, identify trends and opportunities for improvement, and communicate relevant insights to senior management.
• Maintain current knowledge of evolving regulatory requirements and industry expectations.

Product Quality & Market Compliance

• Support the assessment and release of finished imported pharmaceutical products for the U.S. market.
• Review Product Quality Reviews (PQRs) and partner with appropriate departments to resolve recommendations and outstanding items.
• Maintain product traceability and organizational readiness to support product recalls when required.
• Oversee the customer complaint process, including investigation, root-cause analysis, cross-functional resolution, and appropriate follow-up.
• Help ensure Guerbet products are distributed only to appropriately authorized customers through established customer qualification processes.

Supplier & Third-Party Quality

• Ensure third-party contractors meet applicable quality and regulatory requirements.
• Prepare, review, maintain, and serve as an appropriate signatory for Technical Quality Agreements and other quality agreements with internal and external partners.
• Provide quality oversight of third-party logistics activities involving pharmaceutical and medical-device products.
• Provide quality input for Request for Quotation (RFQ) activities and other business processes as required.

YOUR BACKGROUND

Education & Experience

• 8+ years of Quality Assurance experience within the pharmaceutical and/or medical device industry.
• Advanced degree in Chemistry, Engineering, Life Sciences, or a related scientific or technical field.
• Demonstrated knowledge of FDA regulations, cGxP requirements, and ISO quality standards, including ISO 13485.
• Hands-on experience working with electronic Quality Management Systems (eQMS) and controlled document management systems.
• Demonstrated experience supporting FDA or other regulatory inspections.
• Strong experience with audit management, CAPA, investigations, and resolution of nonconformities.
• Strong technical writing skills with experience developing, reviewing, and improving SOPs and quality processes.
• Experience managing or supporting quality agreements and third-party quality activities.
• Previous consulting experience related to SOP development is preferred.
• Knowledge of the radiology or diagnostic imaging environment is a plus.