Ph3Overview /h3pAt 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 /ppbJob Function /b: Quality /ppbJob Sub Function /b: Customer/Commercial Quality /ppbJob Category /b: Professional /ppbAll Job Posting Locations: /b Milano, Italy /ph3Job Description /h3pThe Commercial Quality Senior Specialist, reporting to the Head of Commercial Quality in Italy Local Operating Company, ensures compliance with pharma regulations and the company’s 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. /ph3Responsibilities /h3ollibRegulatory Compliance /bulliEnsure company technical, distribution and administrative activities comply with pharmaceutical legislation. /liliMaintain up-to-date knowledge of relevant laws, GMP and GDP requirements, and guidelines related to controlled substances. /liliImplement and verify the technical and administrative completeness of regulatory documentation. /li /ul /lilibQuality Management Assurance /bulliSupport implementation and maintenance of the Quality Manual and JnJ standards. /liliHelp ensure alignment with PharmaTrade Association guidelines. /liliSupport activities required to obtain and maintain ISO 9001 certification. /liliAct as a certified Internal Auditor to monitor and control the company’s Quality Management System. /liliSupport corporate and third-party audits. /li /ul /lilibSupplier Supply Chain Quality /bulliPerform quality activities for supplier evaluation, supplier ASL maintenance and ongoing monitoring. /liliManage day-to-day supply chain quality activities, including labelling changes and related controls. /liliLead and participate in local and regional projects affecting supply and quality. /li /ul /lilibIncident, Nonconformance Change Control /bulliManage complaints and temperature excursion incidents. /liliOversee nonconformances: perform root cause analysis, develop corrective/preventive actions, and track implementation and follow-up. /liliManage Change Control processes and participate in local escalations. /liliCoordinate responses to temporary shortages and related internal, regional and health-authority communications. /li /ul /lilibReporting, Metrics Continuous Improvement /bulliEnsure regulatory requirements, lessons learned and procedural changes are documented and communicated. /liliCollect and report quality compliance metrics and KPIs for management review. /liliIdentify efficiency and simplification opportunities, and support removal of duplications across processes. /li /ul /li /olh3Required Knowledge Attributes /h3ulliStrong knowledge of pharmaceutical regulations, GMP and GDP. /liliExperience with quality systems, auditing and ISO 9001 processes. /liliDetail-oriented with strong documentation, investigation and communication skills. /li /ulh3Relations /h3pbInternal /b: All Company functions, EMEA/Global Quality organizations. /ppbExternal /b: Health Authorities, Pharma Trade Association, ISO 9001 and External Certification Bodies. /ph3Background /h3pbAcademic and professional background: /b University Degree in Pharmacy, Biology, Chemistry or related Life Science is preferred element. /ppbYears of Experience /b: 3 - 5 years in pharmaceutical Industry, Commercial Quality experience is a plus. /ppbPreferred /b: External Body Qualification as Internal Auditor. /ppbLanguage Knowledge: /b Italian and English. /ppbComputer Knowledge: /b Advanced technical understanding required; AI knowledge is a plus. /ph3Other Skills Knowledge /h3ulliKnowledge of Local International regulations, as well as related JJ policies. /liliKnowledge of tools and procedures for internal and external audits according to ISO requirements. /liliAbility in transferring key policies to external vendors, aligning them to Company’s procedures. /liliMonitoring processes efficiency by measuring KPIs in related dashboard and planning actions for improvement for Process excellence. /li /ulh3Required Skills /h3pbPreferred 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 /p #J-18808-Ljbffr