Sr Mgr Quality Systems Car-t

Il y a 2 mois


Antwerpen, Belgique Johnson & Johnson Temps plein

Within J&J Innovative Medicine Advanced Therapies Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a QA Senior Manager - Quality Systems CAR-T (M/F/X). As member of our Quality team overseeing the Quality Systems (QS) processes, you will be based in Beerse, Belgium or Ghent, Belgium.

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.

J&J Innovative Medicine Advanced Therapies Supply Chain serves as Centre of Excellence for the manufacturing of CAR-T drug product for clinical and commercial purposes. The EMEA CAR-T Drug Product Supply Chain has two manufacturing sites in Ghent (Obelisc & Tech Lane) and the Cryo & QC activities in Beerse, Belgium.

As QA Senior Manager - Quality Systems CAR-T, you are Subject Matter Expert of the Quality System processes, such as change control, non-conformance management, document management, records management, training,You drive the implementation at the Ghent Obelisc, Ghent Tech Lane & Beerse sites and ensure adherence to the Quality System. In this role you report directly to the Site Quality Head.

In this role you are responsible to:

- Establish and maintain effective and strong working relationships with Supply Chain, local and global quality functions of J&J Innovative Medicine and our collaboration partner Legend Biotech to ensure compliance with all quality system requirements.
- Act as QA Point of Contact for the Ghent/Beerse site ensuring QS are appropriately implemented and applied.
- Act as local Process Owner for Quality System processes such as change control, non-conformance handling, document management, records management and training by:
‒ Acting as local Subject Matter Expert, including ensuring GMP documentation is in place and training provided ensuring compliance with global regulations and J&J quality requirements.

‒ Providing support to local users and quality approvers.

‒ Driving the site to continuously strengthen related skill sets across the entire organization.

‒ Evaluating trends and defining appropriate actions.

‒ Defining, following up and concluding corrective and preventive actions related to the QS processes.

‒ Leading the periodic governance meeting to guarantee quality oversight, including escalation to senior management when risks are identified.
- Ensure that quality records such as change controls, non-conformances and CAPAs are timely and properly handled by providing quality, compliance and technical expertise such that the internal and external customer expectations are met.
- With focus on Quality processes, develop and foster an environment of innovative thinking through e.g. benchmark and training. Continuously challenge the status quo by identifying opportunities for continuous improvement.
- Lead the training and development team on quality-related topics and systems.
- Lead and participate in continuous improvement initiatives on the QS processes.
- Act as spokesperson during Health Authority inspections and customer audits.

**Qualifications**:

- Master Scientific degree with a technical specialization in analytics / chemistry / biotechnology / pharmaceutical sciences / engineering (or equivalent through experience).
- In-depth knowledge of cGMP (domestic & international), ICH guidelines, policies, standards and procedures.
- 5-10 years of experience in Quality Systems or Quality Assurance related to manufacturing is required.
- Experience with Data Analysis and continuous improvement methodologies is an asset.
- Experience in people leadership is a must.
- Experience with Health Authority inspections is an asset.
- You work accurately and proactively seek solutions.
- You have good verbal and written communication skills.
- You speak and write Dutch and English fluently.
- Strong analytical thinking skills and able to work in a flexible way under time pressure in local and global teams. Ability to make risk based decisions under time pressure. Understands the business implications regarding quality positions and decisions.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.



  • Antwerpen, Belgique Johnson & Johnson Temps plein

    **Sr. Project manager Engineering & Property Services**: **Johnson & Johnson is recruiting for a Sr Project Manager, located in Geel (Belgium)** At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to...


  • Antwerpen, Belgique Johnson & Johnson Temps plein

    **Sr QA Release Responsible New Product Introduction (M/F/X)** 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...

  • Quality Systems Manager

    Il y a 5 mois


    Antwerpen, Belgique Johnson & Johnson Temps plein

    Within J&J Innovative Medicine Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a **QA Manager - Quality Systems (M/F/X). **You will be a member of our Quality team overseeing the Quality Systems (QS) processes, based in Geel, Belgium. J&J Innovative Medicine Supply Chain in Geel serves as Centre of Excellence for the...

  • Sr. Manager

    Il y a 5 mois


    Antwerpen, Belgique Johnson & Johnson Temps plein

    The Janssen Supply Group, a member of the Johnson & Johnson family of companies, is opening a position for a Sr. Manager - Platform Data Governance & Integrity Lead for the design, deployment, and sustainability of the Pharm Data Governance & Integrity Process. Position can be based in any of our Operating Companies globally. - *This role can be filled fully...


  • Antwerpen, Belgique Johnson & Johnson Temps plein

    Pharm Transcend is a global business transformation program that will modernize our foundational transactional processes and harmonize them into one “clean” ERP as a standardized platform for growth and efficiency gains. The program will simplify the Pharm ERP landscape from 7 to 1, standardizing processes in order to have a cost effective, fit for...


  • Antwerpen, Belgique Experis Temps plein

    Location: **Antwerpen** **#24086** Vast Contract - Regio Antwerpen **#IT #quality #GxP** Onze partner is op zoek naar een IT Quality System Coördinator om hun IT team te versterken. Dit gerenommeerd dienstverlenend bedrijf is gelegen in **Antwerpen **en biedt een breed gamma aan services in diverse industrieën zoals petrochemie, voeding, farma,. Ben je...

  • QA Lab Associate Car-t

    Il y a 6 mois


    Antwerpen, Belgique Johnson & Johnson Temps plein

    The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QA Lab associate for the CAR-T hub in Europe. The position will be based in Beerse Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is a new way to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. The...

  • Sr Formulation Scientist

    Il y a 5 mois


    Antwerpen, Belgique Johnson & Johnson Temps plein

    For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s...


  • Antwerpen, Belgique Johnson & Johnson Temps plein

    The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QC Supervisor for the CAR-T hub in Europe. The position will be based in Beerse Belgium. 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...


  • Antwerpen, Belgique Johnson & Johnson Temps plein

    The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QA Associate for the CAR-T Cryo Lab in Europe. The position will be based in Beerse. 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...


  • Antwerpen, Belgique Selecto Temps plein

    **HDI Global?**: HDI Global SE is een wereldwijd toonaangevende verzekeraar van (grote en internationale) ondernemingen. De maatschappij biedt op maat gemaakte verzekeringsoplossingen voor bedrijven via een netwerk dat meer dan 175 landen bestrijkt. In België legt HDI zich, vanuit haar kantoren in Brussel en Antwerpen met meer dan 90 ervaren collega‘s toe...


  • Antwerpen, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson is recruiting for our Sr. Director, Deliver Emerging Capabilities (Risk, Network, Digital & Data, and NPI) located in either Beerse, Belgium, Zug, Switzerland, Tokyo, Japan, Raritan, NJ, Titusville, NJ, or Somerset, NJ. The Sr. Director, Deliver Emerging Capabilities, will be a strategic leader responsible for ensuring the Johnson &...


  • Antwerpen, Belgique Johnson & Johnson Temps plein

    The Senior Quality Excellence Manager, Advanced Therapies is an exempt level position. Manager's responsibilities include leading and providing quality oversight over a wide range of projects and activities within and beyond the internal & external vaccine, cell and gene therapy manufacturing facilities to support both clinical and commercial requirements....


  • Antwerpen, Belgique Elanco Temps plein

    Education : EQUIVALENTEXPERIENCE **At Elanco (NYSE: ELAN) - it all starts with animals!** **As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to...

  • Quality Manager

    Il y a 5 mois


    Antwerpen, Belgique Emerson Temps plein

    The Quality Manager is tasked with maintaining and enhancing the Quality Management System (QMS) to uphold compliance with ISO 9001, API 6D, and PED certifications. They cultivate a quality-centric culture throughout the organization by employing effective communication, training, and the implementation of specific quality engineering techniques....

  • Sr Manager

    Il y a 6 mois


    Antwerpen, Belgique Johnson & Johnson Temps plein

    This **Sr Manager - QA Clinical Supply Chain **reports to the IMP Qualified Person, and acts as a back-up QP, actively supporting the QP certification activities for investigational products, with a primary focus on products in early development (Small Molecules, Large Molecules and Advanced Therapies) and acts as a key spokesperson during inspections. This...

  • IT Support Specialist

    Il y a 6 mois


    Antwerpen, Belgique Sharp Brains Ltd Temps plein

    **Job Description - Deskside Support** 1. The Deskside engineer will be L1 Skill level with at least 3-4 Years of relevant experience - End user domain and support handling the Incident /SR as assigned for resolution. 3. Provides Desktop support and support for Computer hardware systems, memory modules, and peripherals. 4. Handle basic issues related to...


  • Antwerpen, Belgique Johnson & Johnson Temps plein

    At Johnson & Johnson, we are working to build a world without disease. Redefining lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. This position manages external partners that collect Apheresis Material and Cell Laboratories that perform...


  • Antwerpen, Belgique Science Talents Temps plein

    **Introduction**: Science Talents is part of House of Talents, an international HR services group specialized in bottleneck professions. You will be working in a no-nonsense environment where team spirit, drive and eagerness to learn are key. We are very open and communicative go-getters who are keen on results and quality. To further strengthen our...


  • Antwerpen, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson is currently seeking a Product Artwork Excellence Senior Manager to join our Product Artwork Team. Product Artwork is part of the Digital Operations&Technical Services (DOTS) organization. We are open to considering this global role to be based at any J&J Innovative Medicine Supply Chain locations. The Product Artwork (PA) consists of 30...