TRD Sr. QA Specialist

Location: Ivrea, Italy #onsite

Role Purpose

Support the pilot plant ramp up and operationalization process through the creation of a compliant manufacturing and QC‑related quality system which comprises master batch records, logbooks, forms, and procedures. Support qualification and validation activities by managing and reviewing the related documentation. Ensure the compliance of all business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, in preparation for external and corporate audits and Health Authority inspections. Maintain site compliance through third‑party management, trainings, change controls, self‑inspections, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators) monitoring.

Major Accountabilities

• Support site qualification and validation activities (advising, review, approval)
• Implementation of quality systems, including documentation management
• Supplier management activities (agreements, oversight, audit)
• Preparation, support and coordination of CAPA follow‑up
• Audit and inspection preparation and support, ensuring applications and certificate maintenance to local HA
• Change control review and approval
• Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID, etc.)
• KPI/KQI trending
• Handling of technical complaints, deviations, and quality events related to Novartis products, systems or processes

Key Performance Indicators

• Successful support of projects with agreed quality and delivery dates, passing internal and external inspections
• Meet quality and timelines for all projects
• Act in accordance with Novartis standards
• Number and severity of cGMP issues identified during internal and external audits
• Year‑end figures within budget; successful coordination of departmental operational activities

Work Experience

• Change control management
• Audit and inspection management
• Compliance risk management
• Good Manufacturing Practices (cGMP)
• GxP experience
• KPI reportingQuality management system

Prerequisites

• Minimum of five years in the pharmaceutical industry (sterile preferred)
• Previous experience in Health Authority inspection support (back‑room / SME)
• Experience with QMS document management
• Fluency in English
• Experience working with electronic quality systems (e.g., change controls, deviations, OOX, complaints, etc.)
• Strong quality mindset, documentation, communication, and cross‑functional collaboration skills

Languages

• Italian
• English

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.