QS Document Management Associate CAR-T

Biopharma Careers; Oost-Vlaanderen; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

Johnson & Johnson is seeking a Quality Systems Document Management Associate CAR-T for Ghent, Belgium. The role supports document and training management within a cGMP cleanroom environment for autologous CAR-T production across clinical trials and commercial operations.

You will administratively manage procedures and related documents (Truvault) and coordinate training (Summit), serving as a key site user and mentor for CAR-T Belgium in global forums.

Qualifications

• A bachelor degree is required.
• Proficiency in English and Dutch (verbal and written) is required.
• Experience with quality/compliance processes (cGMP) is desirable.

Responsabilités

• Provide administrative support in document management and training management with compliant and efficient processes.
• Provide admin support throughout the lifecycle of document management (procedures and related documents in Truvault).
• Manage training setup in Summit.
• Fulfill site key user responsibilities: represent CAR-T Belgium in global forums and team meetings, mentor site users for the document management process, and control access to the system.
• Maintain a clear archive in line with Worldwide RIM policies.
• Perform tasks in line with Janssen/Johnson & Johnson policies and cGMP requirements.
• Attend team meetings and training; participate in process improvements and coaching.

Connaissances

Dutch

English

Communication skills

Team player

Formation

Bachelor's degree

Outils

Truvault

Summit

Description du poste

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Non-Standard

Job Sub Function

Workday Associate B

Job Category

Non-Standard

All Job Posting Locations

Gent, East Flanders, Belgium

Job Description

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen.

We are searching for the best talent for a Quality Systems Document Management Associate CAR-T in Ghent.

The QS Document Management Associate CAR-T is responsible for quality systems document management support of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. Administrative Support within the Document & Training Management team.

You will be responsible for:

• Providing administrative support in both document management and training management, with a focus on compliant and efficient processes.
• Provide administrative support throughout the lifecycle of document management: Management of procedures and related documents in Truvault
• Management of training setup in Summit
• Fulfill the site key user responsibilities: represent CAR-T Belgium in global forums and team meetings, mentor site users for the document management process, and control access to the system
• Maintain a clear archive in line with Worldwide Record Information Management policies
• Perform tasks in accordance with Janssen/Johnson & Johnson policies, quality systems, and cGMP requirements
• Attend regularly scheduled team meetings and training
• May participate in process improvement and training
• May be assigned as a coach or mentor to less experienced colleagues

Experience and Skills

• A bachelor degree is required
• Preferred languages: Dutch, English
• Experience with document management systems (Truvault) and training platforms (Summit), but this is not considered a must
• Familiarity with quality and compliance processes (cGMP)
• Proactive, initiative-taking, and capable of implementing improvements
• Proficiency in English and Dutch (verbal and written), as well as good personal communication skills are required
• You have a quality mindset, keeping customer requirements in mind
• You are flexible to support shifting priorities
• You are a team player that gets energized by collaborating with colleagues and providing support to the site users

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.