Johnson & Johnson
Data Integrity Specialist QA-CSV
Data Integrity Specialist QA-CSV
Location: Beerse, Belgium (Hybrid - 3 days on site)
Duration of the contract: Until December 2026
Hours per week: 40 hours
Imagine your next project ensuring the digital heartbeat of life-saving medicine remains uncompromisingly compliant. We as the QA CSV group belong to the Quality organization of Johnson & Johnson Innovative Medicine Supply Chain (IMSC). We are responsible for the quality and compliance of systems across the J&J Belgian Campus, covering commercial and clinical activities in Beerse, Olen, and Geel.
To strengthen this team, we are looking for a Data Integrity Specialist QA-CSV to focus on Innovative Medicine Supply Chain systems, bridging the gap between technical innovation and regulatory excellence.
roles and responsibilities
You will act as the local Data Integrity Specialist and Process Owner for the Beerse site, ensuring our systems and equipment meet the highest global standards.
This will involve:
Cooperate with multifunctional teams to assess local systems and equipment
Define risks and vulnerabilities for the local systems and equipment
Provide DI guidance and support towards local SME’s
Define remediation activities and create Data Integrity plans
Report to the Site Quality Data Integrity Lead
Support the Small Molecules Data Integrity Community of Practice
Prepare for and act as SME during audits and inspections by regulatory agencies
how to succeed
You are a Quality-minded professional who thrives on technical accuracy and has the communication skills to connect with diverse partners across Engineering and IT.
You will also bring:
Master scientific degree or equivalent experience.
At least 3 years’ experience in the pharmaceutical industry.
In-depth knowledge of cGMP/CSV compliance (21 CFR Parts 11, 210, 211; Eudralex 4, Annex 11; GAMP).
Proven experience with Data Integrity remediation activities.
Fluency in verbal and written communication in English and Dutch.
Strong ownership and the ability to deliver on commitment timelines.
Experience with Computerized System Validation (CSV).
benefits
This role offers a very competitive hourly rate. This contract will run until December 2026.
you are welcome here
Johnson & Johnson is 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.
about Johnson & Johnson Innovative Medicine
Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow. Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.
application process
We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email.
Diversity, Equity & Inclusion
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 are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each 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”.