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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