Quality Training Specialist (Raleigh, US)

Guerbet; Raleigh (NC); On-site; USD 65,000 - 95,000; Full time

Job summary

Guerbet is seeking a Quality Training Specialist in the United States (Raleigh, NC) to develop and manage GMP training programs across site operations. The role ensures regulatory compliance, data integrity, and effective knowledge transfer through the Learning Management System (LMS).

Collaboration with cross‑functional teams will drive training effectiveness and continuous improvement. The ideal candidate has a scientific/technical degree with 2–5+ years in regulated environments, strong

Qualifications

• Bachelor’s degree in a scientific, technical, or related discipline.
• 2–5+ years of experience in a regulated environment (pharma, 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 (Word, Excel, PowerPoint).
• Advanced degree or certification in Training, Education, Quality, or related field (preferred).
• Experience in QA, manufacturing operations, or training within a GMP environment (preferred).
• Prior experience with LMS administration, reporting, or system implementation (preferred).
• Knowledge of instructional design principles and adult learning methodologies (preferred).
• Experience supporting audits, inspections, or regulatory interactions (preferred).
• Familiarity with electronic quality systems (e.g., document management, deviation/CAPA systems) (preferred).
• Experience with continuous improvement tools (e.g., Lean, Six Sigma) (preferred).

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
• Performs other duties as assigned by management

Skills

GMP knowledge

LMS familiarity

Documentation practice

Organizational skills

Communication skills

Problem solving

Microsoft Office

Education

Bachelor’s degree in a scientific, technical, or related discipline

Tools

LMS

Job description

Quality Training Specialist M/F (30691)

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.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

WHAT WE ARE LOOKING FOR

The Quality Training Specialist operates 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 Quality Training Specialist supports the development and execution of training programs that ensure compliance with regulatory requirements and quality standards across site operations. This role partners with cross‑functional teams to drive training effectiveness, promote a culture of quality, and support continuous improvement through effective knowledge transfer and performance readiness.

YOUR ROLE

• 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
• Performs other duties as assigned by management

YOUR BACKGROUND

Required Qualifications

• 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)

Reason to join US

Much more than a Competitive salary,

We offer continued personal development. When you join Guerbet, you :

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
• Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
• Are joining a company where we value diversity of talents coming from various horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet.

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to [e-mail] or you can also call this number [phone]