• Perform single case medical assessment, including the determination of seriousness, expectedness/listedness/labeledness, and causality of adverse events in compliance with current regulations, internal and external guidance documents, Standard Operating Procedures, Safety Job Aids, the Argus User Reference Guide and case processing/coding conventions.
• Maintain the timely submission of expedited reports.
• Support the achievement of the Therapeutic Area’s case processing performance timelines.  Identify cases that meet SUSAR reporting criteria, prepare the SUSAR narrative, perform risk assessment, initiate the unblinding process (as appropriate), and make the report available for distribution.
• Take responsibility for inspection readiness for medical assessment activities; support regulatory authority inspections when needed.
• Develop and maintain comprehensive and current knowledge (e.g., indications, labeling documents, pharmacology) for the assigned product portfolio, current regulations governing the processing and reporting of safety data, Standard Operating Procedures, Safety Job Aids, and case processing/coding conventions, consistently completing curriculum training by the specified due dates.

• Definizione della strategia e del business plan, in accordo con i target di profittabilità concordati con la Direzione Aziendale per segmento, progetto e clienti;
• Monitoraggio del mercato, delle opportunità di business e costruzione di una robusta pipeline di clienti e opportunità;
• Coordinamento di un team di vendita: definizione obiettivi, monitoraggio delle performance, supporto nella gestione di situazione complesse;
• Sviluppo delle competenze del team, attraverso coaching e iniziative specifiche;
• Gestione di Key Clients, delle trattative complesse e sviluppo del mercato;
• Ottimizzazione dei processi di vendita e integrazione con tutte le funzioni aziendali coinvolte.

• Supportare il responsabile dell’area Enterprise Architecture nella definizione e realizzazione della strategia evolutiva di medio-lungo termine delle architetture e dei concept funzionali;
• Redigere la documentazione di policy e standard aziendali;
• Supportare nelle fasi RFI, RFP e RDA dei progetti;
• Definire business case per valutazione costi/benefici degli interventi architetturali;
• Supportare il Design Architetturale delle iniziative progettuali, identificando evoluzioni architetturali e soluzioni tecniche/tecnologiche a partire dal requisito business e dal contesto applicativo esistente;
• Redigere i deliverables di progetto indicati dalla metodologia Enterprise Architecture di A2A;
• Garantire la convergenza applicativa delle soluzioni individuate durante le iniziative progettuali (esempi: sistemi Master Data, ottimizzazione e riutilizzo dei sistemi/funzionalità/applicativi);
• Supportare l’analisi di dettaglio dei flussi di integrazione basati su piattaforme middleware ed Api Management (gradita la conoscenza della piattaforma Tibco);
• Contribuire per la propria parte di competenza al miglioramento continuo di best practices, processi aziendali e aggiornamento delle mappe applicative;
• Effettuare scouting e valutazione tecnico-funzionale delle tecnologie di mercato, anche mediante il disegno e realizzazione di “proof of concepts” innovativi.

The role

• Ensures QC performs release testing of products (sterile, non-sterile), raw materials, packaging components, stability studies, environmental monitoring
• Contributes to the development and maintenance of a positive, team-focused company culture and a culture of quality by collaborating across all departments and levels of management to accomplish company objectives and represent QC
• Ensures the QC meets or exceeds Company’s standards for data integrity 
• Establishes processes and ensures collection, analysis, assessment and approval of data to support annual product quality reviews, specifications, stability, and product quality trending
• Ensures QC provides analytical support for process and cleaning validation, and process deviations
• Directly interfaces with contract laboratories, regulators and Quality Assurance in support of internal and external audits and inspections of the Site, including inspection readiness activities
• Identifies opportunities for improvement of methods, processes, and systems to assure the quality of testing of product manufactured at the Site. Provides input and change management ownership for quality improvements affecting QC methods and processes
• Development and implementation of testing-related Quality Management System processes. Create, maintain, and revise QC SOPs and documents that support the Quality Management System
• Ensure that the QC organization meets key performance indicator goals. Includes meeting and exceeding internal stakeholder and customer expectations
• Builds and maintains expertise in the QC organization, through development of staff to ensure that the QC organization supports manufacturing operations and analytical development activities where required.
• Assess and evaluate the introduction and replacement of equipment 
• Ensure Technical support to the Purchasing Department for consumer materials by analyzing new proposals from providers, introducing more efficacious ingredients, supporting the description in the specification of the supply and the certification of providers so to meet the efficiency and efficacy target related cost savings. 
• Supports the QP by providing the information needed to release the batch and reporting quality events like (deviations, out of specifications) that constitute a risk to product quality or compliance. Ensuring that all the information needed by the QP is promptly reported
• Collaborates with the Analytical Development team for activities related to technology transfer and analytical method validation
• Ensures that deviations are appropriately investigated, and that corrective and preventive actions are effectively implemented

Il sito italiano, ubicato in provincia di Novara, è l’HQ Europeo del Gruppo ed è in forte crescita dal punto di vista della capacità produttiva. 

La figura, inserita in suddetto sito, sarà coinvolta, insieme al Site Director, nelle attività di sviluppo e potenziamento del Plant, occupandosi della gestione di tutte le attività di Supply Chain con particolare focus sull’area Acquisti, Planning, Logistica. 

Rispondendo direttamente all’Amministratore Delegato, avrà la responsabilità di un team di collaboratori e sarà competente per tutti gli stabilimenti italiani del Gruppo. 

Si prevede un Inquadramento Dirigenziale. 

• Define the hiring, talent attraction and employer branding strategies to recruit and hire the best candidates according to the specific competencies, knowledge, skills for the requested roles and task;
• Contribute to prepare budget plans concerning personnel costs;
• Partner with local leadership and HR team to design and deliver high-value people plans;
• Partner with local authorities to ensure compliance with laws and requirements;
• Reinforce Employer Branding, Talent Scouting and knowledge sharing partnering with universities, masters’ schools and training companies;
• Prepare and manage a strategical Workforce Planning and coordinate the implementation of the processes and procedures;
• Define competencies matrix to identify skills gaps;
• Assess the plant’s population in order to identify skilled employees ready to support the new Business Line;
• Define the training and development plans for the resources.

• Digital M&S: step by step develop approaches for digital Marketing (e.g. electronically generated qualified lead that can be handed over to the “traditional” field sales team) and digital sales solutions.
• Applications & Tools: select, implement and ensure a harmonized use of digital M&S solutions (e.g. Salesforce.com, PowerBI, eTendering etc.).
• Clinical IT: develop, realize and implement digital solutions complementing the product offer for and with our customers in close collaboration with the M&S colleagues; management of external software providers, responsible for the software development.
• Innovation: to act as advocate with internal and external stakeholders for digital innovation and change management.