DATA INTEGRITY EXPERT

(2410) Genzyme Flanders BVBA

Geel

Hybrid

EUR 68,000 - 90,000

Full time

4 days ago
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Job summary

Sanofi in Geel, Belgium, is seeking a Data Integrity Expert to ensure data reliability and regulatory compliance for medicines. The role involves data quality checks, CAPA, training, and supporting regulatory inspections in a hybrid setup (3 days on site, 2 days home office).

The salary range is disclosed and reflects experience and location. Ideal candidates will have 5 years of pharma data integrity experience, strong analytical skills, and the ability to lead multi-project initiatives while

Qualifications

  • 5 years of experience ensuring data integrity compliance in pharma.
  • Ability to analyze complex data sets and identify patterns.
  • Proven ability to manage multiple projects and deliver on time.
  • Experience with regulatory data practices and documentation.
  • Skilled in data quality checks, audits, and CAPA.

Responsibilities

  • Ensure compliance with data integrity regulatory requirements.
  • Conduct routine data quality checks and validations.
  • Develop and deliver training on data integrity.
  • Identify data integrity risks and implement mitigations.
  • Ensure proper data recording, storage, and retrieval.
  • Investigate data integrity incidents and lead CAPA.
  • Oversee continuous improvement for data integrity.
  • Support inspections and audits related to data integrity.
  • Generate and review DIMM-related reports and metrics.
  • Represent site DI CoP and, if needed, COE participation.

Skills

Data integrity
Data quality checks
CAPA
Documentation
Training programs
Regulatory compliance
Computerized systems

Tools

Computerized systems validation

Job description

Title: R2876285 DATA INTEGRITY EXPERT

Location: Belgium - Geel

Work Arrangements: Hybrid (3 days on site, 2 days home office)

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 do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

Equal opportunities

At Sanofi, we provide equal 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.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.

Salary

The salary range for this position is :€67 835,67 - €90 448 Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors.

Employees may be eligible to participate in Company employee benefit programs.

We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.

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