DATA INTEGRITY EXPERT

Sanofi Group; Winkelom; Hybride; EUR 70 000 - 105 000; Plein temps

Résumé du poste

Sanofi Geel is seeking a Data Integrity Expert to ensure that the data behind our medicines is reliable, compliant and trustworthy, so patients can count on the quality we deliver. You will perform data quality checks, implement CAPA, oversee documentation practices, and deliver training on data integrity while supporting regulatory inspections.

This role requires 5 years of pharmaceutical experience, strong analytical skills and collaboration across functions in a hybrid setup (3 days onsite, 2

Qualifications

• 5+ years of pharma data integrity compliance experience.
• Able to analyze complex datasets and identify patterns.
• Ability to manage multiple projects and deadlines.
• Strong communication and training capabilities.

Responsabilités

• Ensure compliance with data integrity regulations and company policies.
• Conduct data quality checks and validations to identify issues.
• Develop and deliver training on data integrity principles.
• Identify data integrity risks and implement mitigations.
• Ensure proper documentation, recording, storage and retrieval.
• Investigate DI incidents and implement CAPA actions.
• Oversee continuous improvement initiatives for DI.
• Support inspections and regulatory audits related to data integrity.
• Generate and review data integrity reports and metrics (e.g., DIMM).
• Represent the site in DI initiatives and cross-site communication.

Connaissances

Data analysis

Regulatory compliance

Data governance

CAPA

Training delivery

Outils

Computerized systems

Description du poste

Title:R2876285 DATA INTEGRITY EXPERT

Location:Belgium - Geel

Work Arrangements:Hybrid(3days onsite,2 dayshomeoffice)

About the job

At Sanofi, we chase the miracles of science to improve people's lives. As Data Integrity Expert, you will make sure that the data behind our medicines is reliable, compliant and trustworthy, so that patients can count on the quality of what we deliver.

Main responsibilities

• Ensure compliance with regulatory requirements and company policies related to data integrity.
• Conduct routine data quality checks and validations to identify and address data integrity issues.
• Develop and deliver training programs on data integrity principles and practices.
• Identify and assess data integrity risks and implement mitigation strategies.
• Ensure proper documentation practices, including data recording, storage and retrieval.
• Investigate data integrity incidents, including potential data breaches or falsified data, and implement corrective and preventive actions (CAPA).
• Oversee continuous improvement initiatives to ensure they meet data integrity requirements.
• Ensure inspection readiness and participate in regulatory inspections and audits related to data integrity.
• Generate and review data integrity reports and metrics for management, in particular the Data Integrity Maturity Model (DIMM).
• Represent the site (DI CoP) locally and, if requested, participate in the Center of Excellence (COE) and ensure local communication.

About you

Experience

• 5 years of experience ensuring compliance with data integrity regulatory requirements in the pharmaceutical industry.
• Ability to analyze complex data sets and identify patterns, discrepancies and areas for improvement.
• Proven ability to manage multiple projects at the same time, prioritize tasks and deliver on time.

Technical skills

• High level of accuracy and attention to detail in data recording, auditing and reporting.
• Strong verbal and written communication skills to train staff, report findings and collaborate with various departments.
• Ability to identify root causes of data integrity issues and develop effective corrective and preventive actions.
• Expertise in using and validating computerized systems and software relevant to data integrity management.

Soft skills

• Attention to detail and rigor in records, regulatory compliance and investigations.
• Collaboration and influence across departments.

Languages

• Local language and English.

Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and dowhat’snever-been-done-before.You’llhelp push boundaries, challengeconvention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives?Let’sPursueProgressand DiscoverExtraordinary – together.

At Sanofi, weprovideequal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.