QS Document Management Associate CAR-T

7555-Janssen Pharmaceutica NV Legal Entity; Oost-Vlaanderen; Sur place; EUR 60 000 - 75 000; Plein temps

Résumé du poste

Johnson & Johnson Ghent seeks a Quality Systems Document Management Associate for CAR‑T. You will support document control and training management in a cGMP cleanroom setting and ensure compliant records for clinical trials and commercial operations.

Responsibilities include managing procedures, archiving, and site user coaching, with English and Dutch language proficiency required. Join a global team dedicated to innovative medicines and patient safety.

Qualifications

• Bachelor degree required.
• Familiarity with Truvault and Summit platforms preferred.
• Familiarity with quality and compliance processes (cGMP).
• Proactive and able to implement improvements; strong communication in English and Dutch.

Responsabilités

• Provide administrative support in document management and training management.
• Manage procedures and related documents in Truvault; manage training setup in Summit.
• Fulfill site key user responsibilities and represent CAR‑T Belgium in global forums.
• Mentor site users for document management and control access to the system.
• Maintain a clear archive in line with Worldwide RM policies; participate in meetings and training.
• May participate in process improvement and training; possible coaching duties.

Connaissances

Quality mindset

Team player

Proactive

English fluency

Dutch fluency

Communication skills

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 aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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: 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

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.