Qa Sterility Assurance Manager, Nerviano Site

Chiesi Group_Disabled; Bardi; In loco; EUR 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Chiesi Group cerca un QA Sterility Assurance Manager per Nerviano (MI). La risorsa definirà e applicherà la strategia di sterilità, supervisionando processi asettici, utilities e HVAC, e coordinando CCS e valutazioni di rischio.

Supporterà ispezioni regolatorie e gestione CAPA, guidando deviazioni e miglioramenti di processo. Il candidato ideale possiede forte esperienza in QA sterilità, conoscenza di Annex 1 e normative FDA, e capacità di leadership in contesti cross-funzionali, con eccellenti

Competenze

• Laurea in Chimica e Tecnologia farmaceutiche, Biotecnologie, Biologia o campi correlati.
• 7+ anni in contesto farmaceutico, di cui almeno 5 in ruoli QA di sterilità.
• Conoscenza approfondita di EU-GMP Annex 1, FDA Guidance e sistemi di qualità e integrità dei dati.
• Buona conoscenza dell'inglese; capacità di guidare team cross-funzionali.

Mansioni

• Definire e attuare la strategia di Sterility Assurance per Nerviano.
• Supervisionare processi asettici e validare utilities e HVAC.
• Coordinare CCS e valutazioni di rischio microbiologico.
• Supportare ispezioni regolatorie e gestione CAPA.
• Gestire deviazioni, trend, indagini su processi asettici.
• Supervisionare monitoraggio ambientale e qualificazione stanze classificate.

Conoscenze

Team leadership

Cross-functional

Root-cause analysis

Problem solving

Organizational skills

English proficiency

Formazione

Degree in Pharmaceutical Chemistry and Technology, Biotechnology, Biology, or related fields

Descrizione del lavoro

Questa posizione è in Chiesi Groupdisabled

Il processo di selezione sarà interamente gestito Chiesi Groupdisabled.

Questa opportunità è disponibile in Nerviano - Italy, Milan - Italy.

--

Who we are Chiesi is an international research-focused biopharmaceutical group with 90 years of experience, present in over 30 countries, with headquarters in Parma, Italy. More than 8,000 employees across the group are united by a single purpose: to promote a healthier world for people, patients, and the planet. This is what drives us in researching, developing, and marketing innovative drugs in our main therapeutic areas. Learn more here. At Chiesi, we think about future generations, promoting sustainable and purpose-driven innovation. This fosters a culture of reliability, transparency, and ethical behavior at all levels. As a Benefit Corporation and certified B Corp, we have integrated sustainability into our statute and constantly measure our impact. Diversity and inclusion are at the heart of our identity. We believe that our differences make us stronger. We are a dynamic ecosystem of passionate and talented people, united by strong values, each bringing unique perspectives that help us continuously challenge the status quo for the better.

Chiesi Global Manufacturing Division The Chiesi Group has three production plants:

• Parma (Italy), the strategic hub for the production and distribution of our products, serving as an international supply center with exports to over 80 countries. Here, solid medicines such as tablets and dry powders for inhalers, solutions and suspensions for inhalations, and sterile suspension vials for endotracheal administration are produced.
• Blois-La Chaussée Saint Victor (France), a center of excellence specialized in the production of Dry Powder Inhalers and Metered Dose Inhalers (MDIs). The site manages direct distribution to customers in the French market and export to other markets, effectively responding to both local and international needs.
• Santana de Parnaiba (Brazil), specialized in the production of pressurized solutions for inhalation therapy (pMDI). Additionally, it has an area dedicated to nasal sprays for the European market.

In 2024, the Biotech Center of Excellence was inaugurated in Parma, a new hub of excellence for the research, development, and production of biological drugs. The Biotech Center of Excellence focuses on biotechnological innovation, with particular attention to the development of monoclonal antibodies, enzymes, and other complex proteins. In 2025, a new investment in Nerviano (Italy) was announced with the construction of a new facility for the production of therapeutic solutions. The facility will be primarily dedicated to the production of low-carbon footprint inhalers, dry powder inhalers, and sterile biological products.

What you will do

The QA Sterility Assurance Manager is responsible for defining, implementing, and overseeing the Sterility Assurance strategy for the Nerviano plant for the production of sterile forms under aseptic conditions. Ensures full compliance with EU GMP regulations, particularly Annex 1, and US FDA cGMP, ensuring that aseptic processes, critical utilities, sterile areas, and laboratory activities are designed and managed to prevent any risk of microbiological, particulate, and pyrogenic contamination. Guides the implementation of Contamination Control Strategies (CCS), continuous improvement, and process quality.

You will be responsible for

• Developing and maintaining the Site Sterility Assurance Program in accordance with EU Annex 1, EU GMP Vol.4, 21 CFR 210/211, and FDA Guidance, supervising microbiological aspects, sterilization, sanitization, disinfection, and bioburden management programs.
• Defining the Contamination Control Strategy (CCS) and ensuring its implementation at the site level, coordinating microbiological risk assessment activities (risk assessment, FMEA…).
• Supervising aseptic processes and supporting the definition of requirements for:
• HVAC and room classification
• Clean utilities (WFI/PW, Clean Steam, Compressed Gas)
• Material and personnel flow
• Equipment design
• Sterilization processes
• Air flow visualization studies (smoke test)
• Supporting the design and validation of facility layout, personnel and material flows, sanitization and sterilization processes, and aseptic manufacturing processes.
• Defining and approving the Aseptic Process Simulation (APS) program, supervising operational activities, reviewing results, and managing associated deviations and trends.
• Defining and supervising the Environmental Monitoring (EM) program: air, surfaces, personnel, and evaluating related microbiological and particulate trends with definition of improvement actions and CAPAs where necessary.
• Managing the qualification strategy for classified rooms.
• Validating cleaning procedures for microbiological contamination control and defining associated holding times.
• Supervising investigations related to deviations concerning:
• aseptic behavior
• environmental and personnel monitoring
• utilities microbiological excursion
• pre-filtration bioburden excursion
• sterility test failure
• APS failure
• Participating in Change Control processes for aseptic equipment/processes, environmental systems, layout, critical procedures, sterilization systems, personnel and material flows, and defining impacts with relative management of site CCS updates.
• Participating in and supporting regulatory inspections (AIFA, EMA, FDA) and defining CAPAs for any non-compliance.
• Monitoring regulatory compliance and updates.

You must have

• Degree in Pharmaceutical Chemistry and Technology, Biotechnology, Biology, or related fields.
• 7+ years in pharmaceutical contexts - production of sterile drugs under aseptic conditions - of which at least 5 in QA sterility assurance roles.
• In-depth knowledge of sterility assurance requirements, EU-GMP Annex 1, EU GMP Parts I & II – Quality management & manufacturing principles, PIC/S PI 007 & PI 012 (harmonized with Annex 1), FDA Guidance - Aseptic Processing, USP <1211> Sterility Assurance, ISO guidelines in the cleanroom area, and ability to apply QRM (ICH Q9), QMS (ICH Q10), and data integrity (ALCOA+).
• Background in team management and cross-functional coordination.
• Excellent knowledge of root cause analysis tools.
• Organizational skills, problem-solving, and teamwork.
• Good knowledge of English.

Location

Nerviano, Milan What we offer Wherever your journey at Chiesi begins, it will lead you to exciting possibilities. Your future is at the center, and we are committed to supporting your development in a dynamic and friendly environment, with access to resources and training at every stage. We offer high-level benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. The compensation package is competitive and includes base salary, performance bonuses, and benefits aligned with the external market. Additionally, we offer flexible work arrangements, remote work options, and tax services for international colleagues, designed to help you thrive.

Chiesi is an equal opportunity employer and is committed to hiring a diverse workforce at all levels. All qualified applicants are considered for employment based on aptitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other criterion protected by law.

--

[#J-MCITY]