Quality Training Specialist

About the role

At Guerbet, we build lasting relationships to enable people to live better. As a global leader in medical imaging, we offer an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions for diagnostic and interventional imaging. A pioneer in contrast products for over 100 years, we continuously innovate to improve diagnosis, prognosis, and quality of life for patients. This role supports the development and execution of training programs that ensure compliance with regulatory requirements and quality standards across site operations, driving training effectiveness and promoting a culture of quality.

Responsibilities

• Act as process owner for the site training system (GMP), including governance, requirements, and continuous improvement.
• Ensure alignment with GMP + internal standards and ALCOA+ principles (data integrity for training records).
• Define Quality expectations for GMP role requirements, qualification/competency evidence, and curriculum assignment rules.
• Provide compliance oversight: trend monitoring, gap analysis, and driving/approving corrective actions when performance drifts.
• Ensure training records are audit-ready (traceable, complete, consistent, inspection-ready).
• Review/approve training materials only for Quality/GMP scope (e.g., Quality training, GMP compliance, SOP/GMP, data integrity).
• Serve as the single Point of Contact (POC) for audits/inspections related to the training system (readiness, presentation, responses, related CAPAs).
• Ensure training impacts are embedded in GMP change controls/projects (impact assessment and closure requirements).
• Support maintenance of the Learning Management System (LMS), including assignment tracking, reporting, and data accuracy.
• Assist with development, revision, and formatting of training materials, curricula, and SOP-related training content.
• Partner with subject matter experts to coordinate training logistics and ensure alignment with operational needs.
• Perform other duties as assigned by management.

Requirements

• Bachelor’s degree in a scientific, technical, or related discipline (or equivalent experience).
• 2–5+ years of experience in a regulated environment (e.g., pharmaceutical, biotech, medical device).
• Knowledge of cGMP regulations and quality systems requirements.
• Experience supporting training programs, learning systems, or compliance-related training activities.
• Familiarity with Learning Management Systems (LMS) and training documentation practices.
• Strong organizational, communication, and problem-solving skills.
• Detail-oriented with the ability to manage multiple priorities in a fast-paced environment.
• Proficiency in Microsoft Office applications (e.g., Word, Excel, PowerPoint).

Preferred Qualifications

• Advanced degree or certification in Training, Education, Quality, or related field.
• Experience in QA, manufacturing operations, or training within a GMP environment.
• Prior experience with LMS administration, reporting, or system implementation.
• Knowledge of instructional design principles and adult learning methodologies.
• Experience supporting audits, inspections, or regulatory interactions.
• Familiarity with electronic quality systems (e.g., document management, deviation/CAPA systems).
• Experience with continuous improvement tools (e.g., Lean, Six Sigma).