Data Integrity Expert Openings at Multiple Levels

Sanofi; Waterford; Hybride; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Sanofi in Waterford, Ireland is recruiting Data Integrity Experts at multiple levels to join the Quality Systems team. The role focuses on embedding data integrity into daily operations and site-wide compliance, with interviews starting imminently.

Based in Waterford, you will help translate regulatory standards into practical working practices, lead data quality checks, trainings, and CAPA actions, and participate in regulatory inspections and audits as needed.

Qualifications

• Focus on data integrity across regulatory requirements.
• Develop and deliver data integrity training programs.
• Lead risk assessments and CAPA for data issues.
• Ensure proper documentation practices and data recording.

Responsabilités

• Ensuring compliance with regulatory requirements and company policies related to data integrity
• Conducting regular routine data quality checks and validations to identify and address any data integrity issue
• Developing and delivering training programs on data integrity principles and practices
• Identifying and assessing risks related to data integrity and implementing mitigation strategies
• Ensuring proper documentation practices are followed, including data recording, storage, and retrieval
• Investigating data integrity incidents, including potential data breaches or falsification incidents, and implementing corrective and preventive actions (CAPA)
• Leading continuous improvement initiatives to enhance data integrity practices
• Overseeing the validation of computerized systems to ensure they meet data integrity requirements
• Ensuring inspection readiness and participating in regulatory inspections and audits related to data integrity
• Generating and reviewing data integrity reports and metrics for management, especially the DIMM (DI Maturity Model)
• Representing the site in the CoP led by global and, if requested, participating in the CoE and ensuring local communication

Connaissances

Data integrity

Regulatory compliance

Data quality checks

Training delivery

Risk assessment

CAPA

Documentation

Data validation

Continuous improvement

Regulatory inspections

Description du poste

Job title: Data Integrity Expert - Multiple Level Openings

• Location: Waterford, Ireland

About the opportunity

We have exciting, active openings for talented Data Integrity Experts to join our Quality Systems team, and we want to hear from you! We're currently recruiting across Specialist and Manager levels, and interviews are starting imminently. Whether you're a Specialist ready to grow or an experienced Manager, we have the right role for you.

Based in Waterford, our Quality team is on a long-term mission to embed Data Integrity at the heart of everything we do - from day-to-day operations to site-wide compliance. As part of Sanofi's global quality network, we translate regulatory and global quality standards into meaningful, practical ways of working. We're growing our expertise in this space and looking to build a community of professionals who are passionate about getting data right, every time.

About Sanofi:

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

What you'll typically work on:

• Ensuring compliance with regulatory requirements and company policies related to data integrity
• Conducting regular routine data quality checks and validations to identify and address any data integrity issue
• Developing and delivering training programs on data integrity principles and practices
• Identifying and assessing risks related to data integrity and implementing mitigation strategies
• Ensuring proper documentation practices are followed, including data recording, storage, and retrieval
• Investigating data integrity incidents, including potential data breaches or falsification incidents, and implementing corrective and preventive actions (CAPA)
• Leading continuous improvement initiatives to enhance data integrity practices
• Overseeing the validation of computerized systems to ensure they meet data integrity requirements
• Ensuring inspection readiness and participating in regulatory inspections and audits related to data integrity
• Generating and reviewing data integrity reports and metrics for management, especially the DIMM (DI Maturity Model)
• Representing the site in the CoP led by global and, if requested, participating in the CoE and ensuring local communication

Why join our community?

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
• Grow, thrive, and make an impact in a workplace that empowers you to bring your best self every day, with pride.
• Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever.
• Develop new skills, explore cross-functional roles, and work in an environment that values growth and discovery.