Johnson & Johnson Careers
Business Quality Supervisor
Pratica Di Mare, Italy
Requisition ID: 1805668162W
Johnson & Johnson is an American multinational company founded in 1886, a world leader in the development of products and devices for the health care, strongly positioned in the Medical Devices market as well as in the Pharmaceutical and Consumer Market.
Every day more than 120,000 employees work in 250 companies of the Group, located in 60 countries.
For the Italian commercial site of Johnson & Johnson Medical (Pratica di Mare-Rome) we are looking for a Business Quality Supervisor to be hired with a permanent contract in the Quality Department who is responsible for guaranteeing that the quality of the medical products is compliant with the requirements with a high focus on the business acumen.
The Business Quality Supervisor have the following main responsibilities:
• Provide supervision on all areas of the Quality Management System (QSM), including, but not limited to Audit Management, CAPA, Distributors and Suppliers Quality Management (Assessment, monitoring, training and qualification to verify the adherence to J&J standards and to regulations);
• Prepare and maintain QMS documentation system: Quality Manual, Operating Procedures (SOP), working Instructions (WI) coordinating with internal and external stakeholders, as necessary;
• Enhance Business and Quality processes to reflect regulatory requirements, JnJ processes and procedures, state of the art practices and drive continuous improvement;
• Collaborate with representatives from other functional areas and external stakeholders (Supplier and Distributors) to facilitate timely and effective investigations, action implementation and effectiveness monitoring in support of CAPA/NC processes;
• Monitor and report QMS metrics with special focus on Quality KPIs’ and maturity scorecards for Suppliers and Distributors, proposing actions to address performance gaps and accelerate improvements;
• Provide audit management support for 3rd Party Inspections and Audits (e.g. MoH, Notified Body, internal and external audits)
• Prepare Suppliers and Distributors audit planning and execute and/or coordinate their audits;
• Support and participate in cross-functional projects when assigned, will facilitate innovations to enhance processes and support business goals, and will assist with other related activities as requested by the BQ Manager;
• Support and supervise other auditors in planning, conducting and reporting of audits;
• Education: minimum of a Master’s degree is any discipline;
• Minimum 4 years of experience in a Quality Department;
• Demonstrated experience within high regulated QMS in: Audit Management (internal and external), NCs and CAPAs management;
• Qualified as Lead Auditor in accordance with ISO 19011 requirements
• Good Knowledge of ISO 9001 and ISO 13485;
• Previous experience in high regulated industry (Medical, Pharma or Consumer Sectors are considered preferable);
• Excellent Computer skills;
• Fluent in speaking, writing, and reading English as well as Italian.
• Excellent influencing and interpersonal skills (communication and listening skills) as well as teaming with third party suppliers to identify and ensure that J&J best practices - or adequate - are utilized;
• Ability to influence and interact at multiple levels of the organization;
• Strong ability to manage problems and urgencies during issue management;
• Ability to manage multiple priorities and deliver excellent results
• Know and follows all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times
• A minimum of 3 years of experience in people management (direct or indirect) is preferred;
Italy-Lazio-Pratica Di Mare
Johnson & Johnson Medical S.p.A. (7257)