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Commercial Quality Senior Specialist
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At 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
Job Function: Quality
Customer/Commercial Quality
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 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.
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.
Act as a certified Internal Auditor to monitor and control the companys Quality Management System.
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:
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.
Ensure regulatory requirements lessons learned and procedural changes are documented and communicated.
Collect and report quality compliance metrics and KPIs for management review.
Experience with quality systems auditing and ISO 9001 processes.
Internal: All Company functions EMEA/Global Quality organizations.
Years of Experience: 3 -5 years in pharmaceutical Industry Commercial Quality experience is a plus.
Language Knowledge: Italian and English.
Computer Knowledge: Monitoring processes efficiency by measuring KPIs in related dashboard and planning actions for improvement for Process excellence.
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
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
Required Experience: Senior IC
Key Skills: Quality Assurance, FDA Regulations, Data Collection, Food Safety Experience, ISO 9001, Mobile Devices, Root cause Analysis, Quality Systems, OSHA, Food Processing, Quality Management, cGMP
Employment Type : Full-Time
