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J&J Family of Companies Manager Quality Excellence in Beerse, Belgium

Manager Quality Excellence JSC Beerse, Belgium

You have a passion for Quality, you have a creative brain and an eye for opportunities... You are data and system savvy, you have the mindset of continuous improvement. You easily connect, a good team spirit is important to you and you are capable to motivate others… this position is waiting for you!

Job Description:

In this role, you are reporting directly to the Site Quality head of the JSC Beerse/Olen organization, where manufacturing, testing and release of commercial medicines are taking place. You are part of the Quality Leadership Team and closely working together with your peers, the Qualified Person, the Quality Operations senior manager, our Quality Systems and the Quality CSV senior manager, as well as our Quality Control director. Being qualified as Qualified Person is an asset as this gives us the opportunity to combine the role of Quality Excellence manager with back-up Qualified Person responsibilities for the legal entity Janssen Pharmaceutica NV.

The role consists of 2 parts, eventual a 3° part (if qualified as Qualified Person);

  • Excellence role:

  • In this role, you act as Single Point of Contact (SPOC) for the global team Transformational Quality; you give the required input for the global JSC-Quality Technology and Data Analytics roadmap, you make sure that the needs of the site are covered and getting the right priority, you support execution/deployment according to the plan

  • In this role, you install/maintain and deploy the right initiatives to improve the Quality & Compliance profile of both Beerse/Olen, you anticipate as much as possible/justified new/upcoming regulations

  • In this role, you own the Quality Risk program of the Beerse/Olen site; all relevant risks are being identified and listed in the Site Risk Register, you do the periodic follow-up on risk reducing actions that have been agreed upon

  • Performance management QA:

  • In this role, you act as SPOC for the global Performance Management team; you share required data where needed, you analyze the data of the Beerse/Olen site and compare/benchmark with other sites, always looking for opportunities to further improve

  • In this role, you are responsible for monitoring the performance of the Quality Assurance team and to identify opportunities to improve in close collaboration with the different business partners

  • In this role, you analyze the Cost of Quality data for the Beerse/Olen site, you support the organization in identifying Cost Improvement projects and support them in delivering according to commitments

  • In this role, you work closely with the Planning department to ensure a smooth execution of the planned orders, making sure that our customers are happy, in this role, you make sure proper resource management processes are in place for the quality organization

  • Back-up Qualified Person Janssen Pharmaceutica NV:

  • In this role, you work closely with the Qualified Person of Janssen Pharmaceutica NV and support as much as possible

  • Country-specific CoA generation

  • Quality Agreements review

  • Coaching of our release responsibles by leading the monthly alignment meeting

  • Acting as back-up SAP key-user for all issues/questions related to release

  • In this role, you act as a qualified Internal Auditor

Qualifications

  • University degree, scientific orientation (pharmaceutical, chemical or biological sciences/engineering)

  • 5 years’ experience in pharmaceutical industry

  • A good understanding of pharmaceutical production (manufacturing and packaging) and the specific technologies that are being applied

  • A good understanding of pharmaceutical legislation, in cGMP regulations (domestic & international), ICH guidelines, policies, standards and procedures

  • Strong analytical thinking, risk assessment, managerial and leadership skills

  • Ability to meet business objectives in a highly dynamic business environment

  • Excellent communicator, ability to building a network and create win-win solutions

Primary Location

Belgium-Antwerp-Beerse-

Organization

Janssen Pharmaceutica N.V. (7555)

Job Function

Quality

Requisition ID

2005814222W

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