QS Associate Risk Management

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 https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Systems

Job Category:
Professional

All Job Posting Locations:
Antwerp, Antwerp, Belgium, BE004 Antwerpseweg 15 17, BE005 Merksem, BE006 Geel, BE007 Olen, BE009 Turnhoutseweg 30, BE017 Turnhout, BE021 ACT Antwerp, Belgium, BE022 GENT, BE023 BE Gent Suzanne Tassierstraat, BE024 Ghent Techlane, Beerse, Antwerp, Belgium, Geel, Antwerp, Belgium, Gent, East Flanders, Belgium, Ghent, East Flanders, Belgium, Merksem, Antwerp, Belgium, Turnhout, Antwerp, Belgium, Zwijnaarde, Belgium, Zwijnaarde, East Flanders, Belgium

Job Description:

Within J&J Innovative Medicine Advanced Therapies Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a QS Associate Risk Management (M/F/X).

As member of our Quality team coordinating the Quality Systems (QS) processes, you will be based in Ghent, Belgium or 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 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 QS Associate Risk Management, you are Subject Matter Expert on the risk management framework.

You drive the implementation at the Ghent Obelisc, Ghent Tech Lane & Beerse sites and ensure adherence to the process.

In this role you report directly to the Quality Systems Manager CAR-T.

Key Responsibilities:



* Implementing an integrated risk management framework in collaboration with key stakeholders and compliant with applicable regulations and J&J quality requirements.


* Identifying key risks related to products, processes and systems with input from different angles including local and global functions of J&J Innovative Medicine, our collaboration partner Legend Biotech, suppliers, Health Authorities, etc.


* Collaborating cross-functionally to assess identified risks and develop risk mitigation plans.


* Supporting the organization in implementing risk mitigation plans.


* Monitoring and reporting on t...