Data Steward

Guerbet; Raleigh (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Guerbet seeks a Data Steward to ensure data integrity and regulatory compliance across QC systems, including LIMS, SAP Quality Management, and eQMS. You will act as a SME, drive data governance, and collaborate with Quality, Manufacturing, Regulatory Affairs, IT, and Supply Chain to enable reliable data-driven decisions.

You will lead data integrity initiatives, maintain data standards, support audits, and contribute to system validation and upgrades while aligning with FDA 21 CFR Part 11 and

Qualifications

• Bachelor's degree required; degree in a scientific, technical, or related field preferred.
• Minimum of five (5) years of experience in a pharmaceutical, biotechnology, medical device, or other regulated environment.
• Working knowledge of cGMP, FDA regulations, data integrity requirements, and quality management systems.
• Experience with LIMS, SAP Quality Management, eQMS, and electronic data management systems.
• Knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ data integrity principles.
• Strong analytical, organizational, troubleshooting, and problem-solving skills.
• Effective written and verbal communication skills with the ability to work cross-functionally.
• Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.

Responsibilities

• Administer and maintain LIMS with data accuracy, integrity, security, and regulatory compliance.
• Ensure compliance with LIMS and linked electronic systems.
• Identify and investigate data or operational anomalies; recommend corrective actions and support validation, control, and audit activities for LIMS within QC.
• Serve as SME for LIMS; provide troubleshooting and ongoing support for the live system.
• Act as QA SME for SAP Quality functions, including review of system changes, master data management, troubleshooting, enhancements, and upgrades.
• Train users on electronic systems, data management processes, and quality requirements.
• Support implementation, validation, and maintenance of new electronic systems and upgrades.
• Author, revise, review, and maintain laboratory procedures and supporting documentation for electronic data systems and quality operations.
• Ensure compliance with FDA regulations, cGMP, data integrity principles, and internal quality management systems.
• Support internal audits, regulatory inspections, data integrity assessments, and remediation activities as required.

Skills

Analytical thinking

Cross-functional collaboration

Troubleshooting

Written and verbal communication

Problem-solving

Education

Bachelor's degree in science or related field

Tools

LIMS

SAP Quality Management

eQMS

CSV

Microsoft Office

Job description

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 Data Steward 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 Data Steward is responsible for ensuring the accuracy, integrity, consistency, security, and compliance of quality-related electronic data across pharmaceutical systems such as LIMS, SAP, and eQMS. This role supports data governance by maintaining data standards, monitoring data quality, and ensuring compliance with FDA 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ principles, while partnering with Quality, Manufacturing, Regulatory Affairs, IT, and Supply Chain teams to enable reliable data-driven decisions and support product quality, patient safety, and regulatory compliance.

YOUR ROLE

• Administer and maintain the Laboratory Information Management System (LIMS), ensuring data accuracy, integrity, security, and regulatory compliance.
• Ensure compliance with the technical and operational requirements of LIMS and associated electronic systems.
• Identify and investigate data or operational anomalies, provide recommendations for corrective actions, and support validation, control, and audit activities related to LIMS within Quality Control (QC).
• Serve as a Subject Matter Expert (SME) for LIMS, providing troubleshooting, issue resolution, and ongoing support for the live system. Maintain the validated and controlled state of the system to ensure continued compliance and operational effectiveness.
• Act as the Quality Assurance SME for SAP Quality functions, including review of system changes, master data management, troubleshooting, enhancements, and system upgrades.
• Train new and existing users on electronic systems, data management processes, and applicable quality requirements.
• Support the implementation, validation, and maintenance of new electronic systems and system upgrades.
• Author, revise, review, and maintain laboratory procedures, specifications, protocols, reports, and supporting documentation required for electronic data systems and quality operations.
• Ensure compliance with FDA regulations, cGMP requirements, data integrity principles, and internal quality management systems.
• Support internal audits, regulatory inspections, data integrity assessments, and remediation activities as required.

YOUR BACKGROUND

Required Qualifications

• Bachelor's degree required; degree in a scientific, technical, or related field preferred.
• Minimum of five (5) years of experience in a pharmaceutical, biotechnology, medical device, or other regulated environment.
• Working knowledge of cGMP, FDA regulations, data integrity requirements, and quality management systems.
• Experience with LIMS, SAP Quality Management, eQMS, and electronic data management systems.
• Knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ data integrity principles.
• Strong analytical, organizational, troubleshooting, and problem-solving skills.
• Effective written and verbal communication skills with the ability to work cross-functionally.
• Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.

Preferred Qualifications

• Experience with computer system validation (CSV) and change control processes.
• Experience supporting audits, regulatory inspections, CAPA, investigations, and quality risk assessments.
• Familiarity with laboratory testing, instrumentation, and Quality Control operations.
• Lean Six Sigma, ASQ, or other quality-related certifications.
• Experience with quality metrics, data analysis, and reporting.

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.