Quality Business owner MES and ERP

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

Quality

Job Sub Function

Quality Systems

Job Category

Professional

All Job Posting Locations

Beerse, Antwerp, Belgium, Cork, Cork, Ireland, Geel, Antwerp, Belgium, Gent, East Flanders, Belgium, Latina, Italy, Leiden, South Holland, Netherlands, Sassenheim, Netherlands, Schaffhausen, Switzerland, Zwijnaarde, Belgium

Job Description

Quality Business owner ERP & MES

Johnson & Johnson Innovative Medicine is recruiting a Quality Business Owner MES & ERP, responsible for global ERP Quality processes such as Batch Release, as well as owning Quality standards in the Next Gen Manufacturing (NGM) MES space. Support for other, related, global manufacturing systems will be added to this role where appropriate.

This position can be based in any of our Operating Companies with a preference for EMEA timezones.

This position allows to grow and evolve together with the transformational programs in ERP and MES that you will be supporting

Key Responsibilities

The main responsibilities of the Quality Business owner MES and ERP are covering global Quality aspects of both ERP and MES systems, as well as other, smaller, related systems.

For NGM MES systems, you will be the Quality global business owner, responsible for Quality processes such as Batch Release. You will also own Quality standards on Master Batch Record (MBR) creation and verification in MES, BR review and related global Quality topics.

For the Innovative Medicines (IM) ERP systems, this role owns the global QA business processes within the QM modules of the legacy ERP systems. Until these systems are phased out with TranSCend, you will be leading global changes to Batch Release, Master Data and other Quality business processes.

With regards to the future replacement of the existing 5 ERP platforms; you will be partnering with the TranSCend team for the Quality business process alignment and transition from the legacy ERP platforms into the new TranSCend/TIME platform.

The role will be collaborating with Quality, DD&AI (formerly: DOTS), JJT, Technical Quality and leadership, Global and site organizations.

Other Areas To Own And Drive

• Business process standardization, alignment and adoption of best practices between all MTO sites, and identify areas of improvements.
• Act as Quality Business Owner for Periodic Reviews, preparation and execution in collaboration with technical and business partners.
• Establish/maintain a network of functional experts/Key Users cross multiple sites who will support the business process definition, driving organizational alignment on key decisions, as well as ensuring adoption of those decisions and new business processes.

In this position, you will have the opportunity to broaden your horizon, build or extend your network, develop new skills, and contribute to the digitalization of our supply chain

Qualifications

• Solid knowledge of either MES or ERP and the related business quality processes. This knowledge may have been built by performing roles such as site/global Quality representative, Project Manager, lead engineer/modeler or comparable in the MES or ERP space.
• A minimum of University/Bachelor’s degree in sciences (e.g., chemistry, biology, pharmacy, information technology, engineering).
• Generally requires 10+ combined years of experience in Quality Assurance, Quality Control, Validation or Engineering in pharmaceutical industry. Proven understanding of the business environment inside a quality organization, across various roles (e.g., quality operations, quality control, quality systems, etc.) is preferred.
• Working knowledge of Quality systems such as: Risk Management, Investigation/CAPA, Change Control, Document Management, Management Review process, etc. required.
• Quality mentality and ability to enable Critical & Design Thinking.
• Strong communication (verbal, written, and presentation) and interpersonal skills, self-awareness and adapta