Quality and Compliance Manager
Quality and Compliance Manager Deliver EDC-Courcelles
Locations: Courcelles, Belgium
Functions: Quality Assurance
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Requisition ID: 1905750595W
Johnson & Johnson Deliver is a global Supply Chain organization that supports operating units across all the Johnson & Johnson Family of Companies.
CLS strives to deliver an exceptional customer experience through leading critical customer facing-functions such as distribution, customer service, logistics and transportation. CLS is a cross sector organization that supports all three sectors of Johnson & Johnson: Medical Device, Pharmaceutical, and Consumer Products.
The Courcelles EDC, part of Deliver organization is a major J&J EMEA distribution hub for medical devices that is serving thousands of internal and external customers.
The Quality Operations Manager reports into EDC-Courcelles Senior Q&C Manager, Deliver Q&C - EMEA and is responsible for the quality and compliance oversight of the operations in EDC-Courcelles, including product receiving, picking, packing, storage, inspection, review of Repack/Relabel records, restriction and disposition of rejected and quarantined products.
This position coordinates closely with the Deliver Operation, Supply Chain, Operating companies and BQ to ensure that EDC-Courcelles processes are consistent with the regards to the end-to-end process and are driven in compliance with local regulations, the J&J Credo, Quality Principles and Policies.
* Lead a team of 5 Quality Engineers.
* Lead activities in multiple areas; product receiving process, disposition of incoming damaged packages according to procedures or predefined agreements with Operating Co, monitoring of product disposition, and quarantine/hold/stop-ship/recall processes.
* Quality support to business projects, acquisitions & divestitures and associated change controls.
* Support synergies between the other Deliver-DCs in EMEA and other regions to share experience and drive harmonization of quality system processes and tools.
* Interact with Operating companies, Supply Chain, Business Quality organizations and project Leads to drive or support end-to-end risk mitigation plan.
* Perform internal and supplier audits as per plan.
* Set-up and drive continuous readiness for FDA, Health Authorities, corporate and external audits.
* Identify opportunities to continuously improve quality and cost in line with Sector and Deliver business objectives.
* Oversight for the identification and communication of temperature control excursions occurring within the DC to appropriate partner and for the oversight for the investigation of temperature control excursions and subsequent remediation activities within the DC.
* Oversight for intaking, capturing and processing of distribution complaints reported to DC, including tracking and trending.
* Quality oversight of the loan kit operations on site.
* Industrial engineer or life science education background.
* 5 to 10 years of experience in related experience required.
* Six Sigma, Lean, 5S or green belt Certification and/or trainings preferred.
* Experience with Warehouse Management Systems (WMS) preferred.
* People management/leadership experience preferred.
* Project management experience and/or PMP/FPX certification preferred.
* Experience in supply chain and distribution processes preferred.
* Ability to relay on risk management approach for making or facilitating decisions.
* Ability to work in a fast paced environment.
The position is located in Courcelles - Belgium.
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