HireDiversity

Courcelles, BELGIQUE

Quality and Compliance (Senior) Manager GMED Courcelles-000008U1

Description

In 2005, Johnson & Johnson decided to reorganize its logistics and supply chain of finished goods for the Medical Devices & Diagnostics (MD&D) product portfolio. The supply chain across the different brands in this portfolio became centrally organized and a central new warehouse was built to replace different smaller (25+) European warehouses. Today this 20.000m² site is fully operational and supplies almost the entire world of the MD&D products. Per day 5000 sales orders are processed and shipped. This warehouse is located in Courcelles (Belgium) and operated by GMED Healthcare BVBA which is responsible for the trading (i.e. buying and selling from/to intercompany) and which legally owns the inventory and hedge contracts. Annual turnover is over 2.200M€ with over 80 J&J Affiliates. Besides the finished goods inventories in the Belgian warehouse, GMED Healthcare BVBA is responsible for inventories in its satellite warehouses and consignment stocks in hospitals across Europe. The total inventory value of GMED is approximately 800M€.

For the GMED distribution activities on the Courcelles site we are currently looking for a Quality and Compliance (Senior) Manager, who will head the Operations Quality and Regulatory Compliance activities on site.
The position is accountable for executing and managing the daily and long term activities of the Quality and Compliance function for the Courcelles Distribution Center in accordance with all Q&C requirements and customer needs.

Your Responsibilities:
- You will be accountable for the oversight and execution of Quality Management Systems and compliance at the Courcelles Distribution Center.
- You will plan, coordinate and direct Q&C programs designed to ensure effective and consistent processes with established standards on Quality and Compliance by performing the duties personally or through members of your team. In particular:
- Assure all customer complaints or deviations related to distribution activities (e.g. temperature excursions), warehouse activities (e.g. damages) and repackaging activities are thoroughly investigated and escalated according to the applicable escalation procedure.
- Ensure all customer returns, which require quality involvement, are handled in a timely manner. Products are investigated physically and impact assessment on quality and compliance is performed, before the products can be taken back into the sellable stock.
- Review and approve changes related to the activities in the DC.
- Perform Quality and Regulatory Compliance Improvement meetings, where trends on deviations and complaints are followed up as well as the implementation of the related corrective and preventive actions (CAPA).
- Perform Quality Management Review meetings according to the applicable J&J Standard.
- Assure internal audits in the warehouse and repackaging department are performed according to the approved plan in order to perform an in-depth review of the operation against the applicable cGMP / GDP or any relevant regulation and J&J requirement.
- Review and approve quality related procedures to assure the day-to-day activities are performed in accordance with the cGMP / GDP or any relevant regulation and J&J requirement.
- Review and approve master data related to distribution activities to assure products are stored according to the required storage conditions and are distributed according to the required transport conditions.
- Act as the Quality Systems Specialist (on eg Traceability, QMS Readiness and Optimization and Part 11 Compliance) and as the Franchise Q&C Specialist.
- You will work in close collaboration with Quality Representatives from the sector organizations (Supply Chain, Franchises and Commercial Organization).

Exigences
- You hold a bachelor or master degree in engineering, scientific, business or QRC disciplines.
- You have a business background with direct experience in the sector of Medical Devices and Diagnostics, with specific quality, regulatory and regulatory compliance competencies in the areas of distribution.
- A minimum of 5 years of experience in a DC Q&C position, with quality management experience is required.
- You can show proven success in:
- Working in a multi-cultural with multi-country healthcare regulatory requirements.
- Issue remediation experience.
- Collaborative approach in leading a team.
- Managing complexity.
- You have a decisive, well organized and hands-on operational approach.
- You have good communication skills, you are able to inspire trust and quickly build credibility within the Quality & Compliance, Supply Chain, and Commercial organizations.
- You have a strong desire to commit and you can be held accountable and be rewarded for delivering results.
- You are fluent in French and English.

Localisation principale: Europe/Moyen Orient/Afrique-Belgique-Hainaut-Courcelles

Organisation: GMED (7548)

Fonction: Quality (Generalist)