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 Assurance **Job Category:** Professional **All Job Posting Locations:** Beerse, Antwerp, Belgium, La Louviere, Hainaut, Belgium **Job Description:** **The primary mission of the role** + Ensure adherence to the Johnson & Johnson Quality Policy and applicable J&J QMS standards related to supply chain GDP activities from Distribution HUB warehouses to the final customer including third-party warehouses (3PLs) oversight and Outbound Transportation (OBF) for specific countries + Serve as the 3PL Oversight Center of Excellence (COE) for the EMEA region, ensuring harmonized processes are implemented across the region and driving continuous improvement in this area + Operate in alignment with Credo Values, Janssen Supply Chain standards, and J&J Delivery Requirements + Comply with Safety, Health, and Environmental principles at all times **Responsibilities within the CQ IM Distribution HUB:** + Support and ensure the operational compliance of European Distribution Centers (DC La Louvière, DC Beerse, EDN) with Good Distribution and Manufacturing Practices within warehouses and repackaging departments + Assist the Site Quality Head in the implementation and maintenance of the Quality System at EDC La Louvière **Activities** **Strategy for 3PL / OBF oversight** Implement the quality strategy in line with regional CQ strategy and local business strategy including: + Oversight, monitoring and improvement of 3PL quality and compliance metrics. + Proactively partner with other functions to ensure quality aspects of new launches, delisting and divestures are properly handled. + Work with functional partners to ensure alignment of Commercial quality initiatives with strategic business direction. **COE for 3PL oversight** + Drive best practices, innovation (data, process, technology), and serve as a resource for guidance, support, and knowledge sharing, helping to improve overall performance + Maintain Regional Operational process mapping + Identify and sponsor local initiatives/projects to increase compliance and to reduce the cost of non-quality/non-conformance. + Identify and sponsor local cross-functional opportunities **Monitoring of 3PLs** + Provide data/information within the organization + Review and improve processes of the QMS, ensure that KPIs are in place. + Responsible for the monitoring activities of the 3PLs + Participate to the 3PL business reviews **Audits & inspections** + Setting up and following 3PL audit plan for the Region + Planning and Leading audits of 3PLs as per audit plan. + Lead, support and follow-up of internal and external inspections. + Support and actively participate to quality internal/external audits and check rounds. This includes audits preparation, audits completion and audits follow-up. **Change control** + Initiate, assess and/or approve Change Controls related to the scope of the function **Documentation** + Write, review and/or approve Work Instructions (WI) and Procedures (SOP) + Collaborate with other departments for documentation content and ensure Good Documentation Practices are followed. **Escalation** + Triggering, leading and/or coordinating local, escalations regarding product quality or compliance issues when the issue is caused by 3PL. **Non- conformities & Complaints** + Initiate, investigate and/or approve Quality Issues, Correctives and Preventives actions and complaints related to distribution activities and repackaging activities **Project** + Participate in the development of projects implementation + Support improvement projects and prepare the organization to take up new responsibilities as result of other projects. **QA on the floor** + Ensure that products are stored, handled, and distributed according to J&J standards and all applicable regulations. + Have oversight of all such activities **Recall & Destruction** + Coordinate the recall and destruction processes. **Supplier Management** + Coordinate the supplier management activities (including suppliers’ approval and maintenance of compliant state). **Risk Management** + Identify, prioritize, and mitigate quality risks related to QA and operationnal processes **Profile we're looking for:** _Knowledge_ + Current Good Manufacturing, Documentation and Distribution practices + GMP (Directive 2003/94/EC-Eudralex volume 4) + GDP (2013/C 343/01) + QA related experience within an operational pharmaceutical environment + External body qualification / Certification as Internal auditor is preferred _Degree_ + Master’s degree _Languages_ + English + Ideally Dutch, French and German _Specific know how of systems_ + SAP + comet + Truvault + Summit + Microsoft Office applications + PQMS **Closing date:** Friday 26th of September