Senior QA Associate – Quality Systems

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:
Geel, Antwerp, Belgium

Job Description:

Within J&J Innovative Medicine Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a Senior QA Associate – Quality Systems (M/F/X).

As a member of our Quality team overseeing the Quality Systems (QS) processes, you will be based in Geel, Belgium.

J&J Innovative Medicine Supply Chain Geel serves as Center of Excellence for the development and manufacturing of Small Molecule API (SM-API) and DP Intermediates used in treatments that improve the health and lifestyle of people worldwide.

J&J Innovative Medicine Supply Chain Quality supports the Geel site in its mission as Launch & Grow site and is responsible for the quality oversight and final release of SM-API and DP Intermediates, guaranteeing reliable supplies in compliance with applicable regulations.

As Senior QA Associate – Quality Systems, you are Subject Matter Expert of Quality System processes such as document management, records management.

You drive the implementation at the Geel site and ensure adherence to the Quality System.

In this role you report directly to the Senior QA Manager.

In this role you are responsible to:


* Establish and maintain strong working relationships with your global Quality Systems partners as well as your local Quality and Supply Chain colleagues


* Act as QA Point of Contact for the Geel site ensuring Quality Systems are appropriately implemented and applied in compliance with global regulations and J&J quality requirements


* Coach cross-functional teams at the site, including Quality professionals


* Act as Local Process Owner for Quality System processes such as document management, records management,… by:
+ Acting as local Subject Matter Expert, ensuring GMP documentation is in place and training provided in compliance with global regulations and J&J quality requirements
+ Providing support to local users and QA 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 Quality System processes


* Ensure that quality records such as change controls, non-conformances and CAPA...