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 jnj.com (https://www.jnj.com.). As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Engineering Job Sub Function: Quality Engineering Job Category: Scientific/Technology All Job Posting Locations: Milano, Italy Job Description: 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 jnj.com. Commercial Quality Executive Essential Job Duties and Responsibilities: Monitoring compliance of the Company's activities to PharmaTrade Association Guidelines and ISO 9001 standards, by monitoring the activities and carrying out the required internal / external audits, ensuring a Total Quality Management System. Pharmaceutical Environment's Regulations: Compliance with pharmaceutical sector legislation for all the technical-administrative activities of the company. up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP, including any legislation/guidelines relating to controlled substances. Implementing and verifying the technical-administrative completeness of documentation. Quality Assurance : Ensure the correct implementation of Commercial Quality Manual and JnJ Standards. Support ensuring the implementation of Pharma Trade Association guidelines. Ensure all activities for obtaining the ISO 9001 certification. Perform auditing activities as Auditor and/or Lead Auditor (internal/external) to ensure monitoring and control of the Company's total Quality management system. Assure that information on regulatory requirements, lessons learned, and procedural changes are properly documented. ? Documentation management key contact and SME for document revision, process oversight and updating and for System Tru Vault management Training management key contact/SME and SUMMIT Business Learning Administrator for Training management and assignment to all company employees, Training materials review and updating and training process oversight for the entire Italian Local Operating Company Ensure appropriate Management and oversight of Nonconformances, root cause analysis, CAPAs and Change control development, monitoring, and follow-up management. Back-up approval role (Nonconformances, root cause analysis, CAPAs and Change control, commitment, escalation, etc on behalf of CQ Head). Participate in local, regional, and global projects. Supplier management SME and point of contact for the local operating company Minimum Qualification University Degree in Pharmacy, Biology, Chemistry or related Life Science is preferred element. At least 2 (ideally 5) years' experience in the Pharmaceutical or related industry, ideally with a mix of Manufacturing / QA operations, Distribution, Warehouse management. Where the position requires oversight of manufacturing / packaging / testing operations activities (internal or external), Manufacturing / QA operations experience is essential. Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers. ? Excellent computer proficiency e.g. MS Office, SAP Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution. ? Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude. Knowledge of Local & International regulations, as well as related J&J policies. Knowledge of tools and procedures for internal and external audits according to ISO requirements. Ability in transferring key policies to external vendors, aligning them to Company's procedures. Monitoring processes efficiency by measuring KPIs in related dashboard and planning actions for improvement for Process excellence. Other requirements: External Body Qualification as Internal Auditor Required Skills: Preferred Skills: