CAR T Manager Process Life Cycle 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:
Supply Chain Engineering

Job Sub Function:
Process Engineering

Job Category:
People Leader

All Job Posting Locations:
Beerse, Antwerp, Belgium, Gent, East Flanders, Belgium

Job Description:

CAR T Manager Process Life Cycle Management
 

Job Description
 

Johnson & Johnson  Innovative Medicine is recruiting for an Manager Process Life Cycle Management, for the MSAT CAR-T organization, located in Ghent Belgium.

The MSAT CAR-T organization is an organization which provides and supports a high degree of assurance that specific processes will consistently produce and meets its pre-determined specifications by deploying process validation, process system engineering, data architecture and continuous process verification and process investigation.

At the Johnson & Johnson Innovative Medicine, we are working to create a world without disease.

Transforming 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.

We collaborate with the world for the health of everyone in it.

Patients are waiting.

 

The CAR-T Manager Process Life Cycle Management will: 


* Partner with local manufacturing, QA/QC, Vein-to-Vein, IT, MAM organizations and global MSAT to define and deploy business compliance strategies on process life cycle management as electronic MBR management, control of change, material & particulates control strategy and knowledge base.


* Will maintain the organizational compliance level and ensure continuous inspection readiness across all MSAT disciplines and functions.


* Takes accountability for process compliance aspects and represent the approach during internal and external Health Authority audits.


* Build and/or maintain strategies in full alignment with global policies to keep compliant documentation processes in place.


* Will manage with the team change control for all process related changes, improvements with local owners and stakeholders.


* Will work in close collaboration with investigation teams, digital & analytic teams, process validation teams to embed process compliance


* Build successful stakeholder relationships by representing MSAT departments in the different functional production areas.


* Leads cross‑functional taskforces to successful completion, driving alignment, removing obstacles, and delivering final objectives on t...