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Job Function:
Quality
Job Sub Function:
Customer/Commercial Quality
Job Category:
Professional
All Job Posting Locations:
Milano, Italy
Job Description:
The 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.
Duties and Responsibilities:
Regulatory Compliance:
* Ensure company technical, distribution and administrative activities comply with pharmaceutical legislation.
* Maintain up-to-date knowledge of relevant laws, GMP and GDP requirements, and guidelines related to controlled substances.
* Implement and verify the technical and administrative completeness of regulatory documentation.
Quality Management & Assurance:
* Support implementation and maintenance of the Quality Manual and JnJ standards.
* Help ensure alignment with PharmaTrade Association guidelines.
* Support activities required to obtain and maintain ISO 9001 certification.
* Act as a certified Internal Auditor to monitor and control the company's Quality Management System.
* Support corporate and third-party audits.
Supplier & Supply Chain Quality:
* Perform quality activities for supplier evaluation, supplier ASL maintenance and ongoing monitoring.
* Manage day-to-day supply chain quality activities, including labelling changes and related controls.
* Lead and participate in local and regional projects affecting supply and quality.
Incident, Nonconformance & Change Control:
* Manage complaints and temperature excursion incidents.
* Oversee nonconformances: perform root cause analysis, develop corrective/preventive actions, and track implementation and follow-up.
* Manage Control of Change processes and participate in local escalations.
* Coordinate responses to temporary shortages and related internal, regional and health-authority communications.
Reporting, Metrics & Continuous Improvement:
* Ensure regulatory requirements, lessons learned and procedural changes are documented and communicated.
* Collect and report quality compliance metrics and KPIs for management review.
* Identify efficiency and simplification opportunities, and support removal of duplications across processes.
Required Knowledge & Attributes:
* Strong knowledge of pharmaceutical regulations, GMP and GDP.
* Experience with quality systems, auditing and ISO 9001 processes.
* Detail-oriented with strong documentation, investigation and communication skills.
Relations:
Internal: All Company functions, EMEA/Global Quality organizations.
External: Health Authorities, Pharma Trade Association, ISO 9001 and External Certification Bodies.
Background:
Academic and professional background: University Degree in Pharmacy, Biology, Chemistry or related Life Science is preferred element.
Years of Experience : 3 -5 years in pharmaceutical Industry, Commercial Quality experience is a plus.
Preferred: External Body Qualification as Internal Auditor.
Language Knowledge: Italian and English.
Computer Knowledge: Advanced technical understanding required; AI knowledge is a plus.
Other Skills and Knowledge:
* 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.
Required Skills:
Preferred Skills:
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