Data StewardWHAT WE ARE LOOKING FORThe 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 BACKGROUNDRequired 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 USMuch 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.
