Johnson & Johnson
Data Integrity Lead / CSV
Data Integrity Lead
Location: Beerse (Remote)
Duration of the contract: Until December 31, 2026 (possible extension)
Hours per week: 40
Imagine your next project leading the evolution of Data Integrity standards across a global healthcare landscape. As the Senior Data Integrity Lead, you will be the driving force behind the implementation of the Annex 11 revision within our Innovative Medicine framework. This is a high-visibility role where your expertise in compliance and project leadership will directly impact how we safeguard the data that brings life-changing medicines to patients.
roles and responsibilities
You will be accountable for project leadership, coordination, and communication related to the Annex 11 revision implementation.
This will involve:
Assess impact of Annex 11 & Chapter 4 changes/additions to IM Data Integrity Framework.
Communicate impact to Data Integrity GPO in collaboration with Enterprise Quality.
Draft enhanced/new requirements into IM Data Integrity Framework.
Finalize and publish revised IM Data Integrity procedures once Annex 11 officially revises.
Design fit for purpose Annex 11 update training.
Deploy Annex 11 update training to target IM audience.
Launch, track and communicate IM local/global Data Integrity procedural updates for deploying the IM Data Integrity Framework revisions, supported by the ARR process.
Facilitate Project Forums/Community of Practice meetings for above site Data Governance in partnership with global Data Integrity leads.
how to succeed
We are looking for a strategic thinker who can navigate complex matrix environments and translate regulatory requirements into actionable quality procedures.
You will also bring:
A minimum of University/Bachelor’s degree in sciences (e.g., chemistry, biology, pharmacy, IT, or engineering).
10+ combined years of experience in Manufacturing, Quality Assurance, or Quality Control within the vaccines/pharmaceutical industry.
Proven knowledge of and experience with Annex 11 & Chapter 4 regulations.
Proven knowledge of applicable Data Integrity regulations.
Working experience within an FDA/EMA GMP (Pharmaceutical) regulated environment.
Working knowledge of Quality systems (Risk Management, Investigation/CAPA, Change Control, etc.).
Strong communication, facilitation, and interpersonal skills.
Project Management skills and experience with process excellence.
Ability to work independently and manage complexity across multi-disciplined, remote teams.
benefits
This role offers a very competitive hourly rate. This contract will run until December 31, 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”.