Data Integrity Subject Matter Expert

Leiden, Netherlands, 40h, 3 days per week on-site

Johnson & Johnson Worksense is responsible for finding, engaging, and contracting talent for the Johnson & Johnson contingent workforce.

We are currently recruiting a Data Integrity Subject Matter Expert to join our contingent workforce in Janssen in Leiden for an initial one-year contract.

As a Data Integrity Subject Matter Expert, you work within the site Data Integrity Team, specifically focusing on manufacturing and analytical systems linked to Covid-19 Vaccine production. You perform and analyze data integrity gap assessments and you propose remediations (technical, procedural, training). You coordinate activities and stakeholders to lead to full gap remediation. Additionally,  you offer guidance and support to the business to improve GMP processes related to DI topics such as Security / User Access Management, Audit Trail Review, Backup & Archival.

As a Data Integrity Subject Matter Expert you will be responsible for:

• Understand both technical and procedural requirements of Data Integrity in manufacturing and analytical environment
• Collaborate with Business System Owners, Technical System Owners, QA, and Training to identify the most efficient action to be taken for any system and at any step of the data flow 
• Analyze data integrity gaps and lead activities toward remediation
• Improve the procedural framework related to DI topics
• Guide Business System Owners and Technical System Owners in meeting current and, prepare for the future expectation of Data Integrity
• Manage work according to a schedule

To be successful in this role you have:

• In-depth, up-to-date knowledge of computerized systems, GMP, and specifically Data Integrity practices and recent developments in this expertise area.
• Independent critical thinking and decision-making to find sound solutions from a structural, regulatory, and business perspective.
• Pharmaceutical or Life Science work experience for 6+ years.
• Experience in a complex, multinational work environment.
• Experience in Quality Assurance is an advantage.
• Knowledge of Computerized Systems Validation is an advantage.

If you meet our requirements and are interested in hearing more about our Data Integrity Subject Matter Expert role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in the Netherlands are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!