PpAt Johnson Johnsonwe 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 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 more at /p pbJob Function: /b Quality /p pbJob Sub Function: /b Customer/Commercial Quality /p pbJob Category: /b Professional /p pbAll Job Posting Locations: /b Milano Italy /p pbJob Description: /b The Commercial Quality Senior Specialist reporting to the Head of Commercial Quality in bItaly Local Operating Company /b ensures compliance with pharma regulations and the companys quality standards across commercial operations. The role supports implementation of GMP/GDP and ISO requirements leads audit and supplier-quality activities manages incidents and change control and tracks KPIs to safeguard product quality and business continuity. /p h3bDuties and Responsibilities: /b /h3 ul liEnsure company technical distribution and administrative activities comply with pharmaceutical legislation. /li liMaintain up-to-date knowledge of relevant laws GMP and GDP requirements and guidelines related to controlled substances. /li liImplement and verify the technical and administrative completeness of regulatory documentation. /li /ul h3bQuality Management Assurance: /b /h3 ul liSupport implementation and maintenance of the Quality Manual and JnJ standards. /li liHelp ensure alignment with PharmaTrade Association guidelines. /li liSupport activities required to obtain and maintain ISO 9001 certification. /li liAct as a certified Internal Auditor to monitor and control the companys Quality Management System. /li liSupport corporate and third-party audits. /li /ul h3bSupplier Supply Chain Quality: /b /h3 ul liPerform quality activities for supplier evaluation supplier ASL maintenance and ongoing monitoring. /li liManage day-to-day supply chain quality activities including labelling changes and related controls. /li liLead and participate in local and regional projects affecting supply and quality. /li /ul h3bIncident Nonconformance Change Control: /b /h3 ul liManage complaints and temperature excursion incidents. /li liOversee nonconformances: perform root cause analysis develop corrective/preventive actions and track implementation and follow-up. /li liManage Control of Change processes and participate in local escalations. /li liCoordinate responses to temporary shortages and related internal regional and health-authority communications. /li /ul h3bReporting Metrics Continuous Improvement: /b /h3 ul liEnsure regulatory requirements lessons learned and procedural changes are documented and communicated. /li liCollect and report quality compliance metrics and KPIs for management review. /li liIdentify efficiency and simplification opportunities and support removal of duplications across processes. /li /ul h3bRequired Knowledge Attributes: /b /h3 ul liStrong knowledge of pharmaceutical regulations GMP and GDP. /li liExperience with quality systems auditing and ISO 9001 processes. /li liDetail-oriented with strong documentation investigation and communication skills. /li /ul h3bRelations: /b /h3 pbInternal /b: All Company functions EMEA/Global Quality organizations. /p pbExternal /b: Health Authorities Pharma Trade Association ISO 9001 and External Certification Bodies. /p h3bBackground: /b /h3 pbAcademic and professional background: /b University Degree in Pharmacy Biology Chemistry or related Life Science is preferred element. /p pbYears of Experience /b: 3 -5 years in pharmaceutical Industry Commercial Quality experience is a plus. /p pbPreferred /b: External Body Qualification as Internal Auditor. /p pbLanguage Knowledge: /b Italian and English. /p pbComputer Knowledge: /b Advanced technical understanding required; AI knowledge is a plus. /p h3bOther Skills and Knowledge: /b /h3 ul liKnowledge of Local International regulations as well as related JJ policies. /li liKnowledge of tools and procedures for internal and external audits according to ISO requirements. /li liAbility in transferring key policies to external vendors aligning them to Companys procedures. /li liMonitoring processes efficiency by measuring KPIs in related dashboard and planning actions for improvement for Process excellence. /li /ul pbRequired Skills: /b Audit Management Business Behavior Coaching Compliance Management Continuous Improvement Data Analysis Detail-Oriented Goal Attainment Internal Controls Issue Escalation Problem Solving Process Oriented Quality Control (QC) Quality Management Systems (QMS) Quality Standards Regulatory Environment /p pbPreferred Skills: /b Audit Management Business Behavior Coaching Compliance Management Continuous Improvement Data Analysis Detail-Oriented Goal Attainment Internal Controls Issue Escalation Problem Solving Process Oriented Quality Control (QC) Quality Management Systems (QMS) Quality Standards Regulatory Environment /p pbRequired Experience: /b Senior IC /p pbKey Skills /b: Quality Assurance, FDA Regulations, Data Collection, Food Safety Experience, ISO 9001, Mobile Devices, Root cause Analysis, Quality Systems, OSHA, Food Processing, Quality Management, cGMP /p pbEmployment Type : /b Full-Time /p pbExperience: /b years /p pbVacancy: /b 1 /p /p #J-18808-Ljbffr