ph3Work Schedule /h3 pFlex Shifts 40 hrs/wk /p h3Environmental Conditions /h3 pOffice /p h3Job Description /h3 pAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale.
Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.
We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
/p h3PURPOSE OF THE ROLE / RESPONSIBILITIES: /h3 pEnsure the governance, effectiveness and compliance of the Quality Management System (QMS), maintaining it in a state of control and continuous improvement, in accordance with applicable regulatory requirements (EU GMP, US FDA, ICH), corporate standards and recognized frameworks.
/p pEnsure independent and unbiased oversight of site GMP systems and processes, guaranteeing effective control, proactive risk identification and continuous professional development aligned with Corporate guidelines, promoting participation in Communities of Practice.
/p pAct as a reference point for Quality Governance and support senior management in data- and risk-based decision-making.
/p h3Quality System Governance (QMS) Oversight /h3 ul liEnsure governance, effectiveness and compliance of the QMS, maintaining state of control and continuous improvement /li liEnsure independent and unbiased oversight of GMP systems and processes, with proactive risk identification /li liLead Quality Management Review and Quality Council, ensuring KPI monitoring and trend analysis /li liDefine, monitor and ensure achievement of quality KPIs, supporting management decision-making /li /ul h3GMP Procedures and Documentation /h3 ul liEnsure management, review, approval and distribution of GMP documentation in compliance with EU/US GMP and corporate standards /li liEnsure proper management and distribution of controlled copies across departments /li liEnsure SOP updates in line with regulatory requirements, including periodic review planning /li liEnsure proper management and issuance of analytical specifications /li liEnsure execution of gap assessments vs corporate standards,



including feedback collection /li liEnsure periodic review of gaps and support functions in their closure /li liMonitor and ensure achievement of KPIs related to procedures and corporate standards /li liEnsure maintenance of qualification status (facilities, equipment, PPQ, cleaning) and VMP update /li /ul h3Change Control /h3 ul liEnsure proper management of Change Control system applied to site processes and systems /li liEnsure management and facilitation of Change Control Board /li liEnsure quality and regulatory impact assessment of changes /li liMonitor and ensure achievement of Change Control KPIs /li /ul h3Training /h3 ul liEnsure effective onboarding process for new hires /li liEnsure management and execution of GMP training /li liEnsure update of training curricula across departments /li liEnsure identification and assessment of current and future training needs /li liPromote innovative training methods (digitalization, augmented reality) /li liMonitor and ensure achievement of training KPIs /li /ul h3Data System Administration (DSA) /h3 ul liEnsure compliance of GMP electronic systems in line with Data Integrity principles /li liEnsure access management and segregation of duties /li liEnsure periodic audit trail review /li liEnsure data backup management /li liSupervise user access and system parameters /li liEnsure compliance of computerized systems in manufacturing and laboratory /li liEnsure controlled management of system changes Computer System Validation (CSV) /li liEnsure all GxP computerized systems are validated and maintained in control per GAMP 5, Annex 11, 21 CFR Part 11 /li liDefine and maintain validation strategy (CSV Master Plan) /li liOversee Risk Assessment, IQ/OQ/PQ and periodic review /li liEnsure proper management of changes to validated systems /li liEnsure completeness and traceability of validation documentation /li liEnsure integration between CSV and Data Integrity /li liSupport audits,



inspections and regulatory activities /li liMonitor KPIs related to computerized systems compliance /li /ul h3Competency Development Corporate Alignment /h3 ul liEnsure continuous professional development of team and QMS functions /li liPromote participation in Corporate Communities of Practice /li liFoster knowledge sharing and alignment with global standards /li /ul h3EHS DUTIES RESPONSIBILITIES: /h3 pRefer to Art. 19 of Legislative Decree ***** and subsequent amendments – Supervisor duties.
/p pSovraintendono alle attività lavorative, nell'ambito delle proprie competenze e attribuzioni, adottando le misure necessarie per salvaguardare l'ambiente, la salute e sicurezza dei lavoratori (riferimento D.Lgs.***** e D.Lgs. ******).
Ai Preposti è delegata la responsabilità di controllare che il lavoro, nell' aree di loro competenza, sia organizzato ed eseguito secondo gli standard di sicurezza richiesti, nel rispetto dei requisiti del Sistema di Gestione della Salute e Sicurezza dei Lavoratori ed Ambientale.
/p pI Preposti hanno la responsabilità di garantire che tutti i dipendenti operino secondo procedure ed istruzioni operative chiare ed adeguate, in un ambiente di lavoro affidabile e nel rispetto dell'ambiente, riferendo ai livelli gerarchicamente superiori le eventuali condizioni di lavoro che presentino rischi non correttamente valutati.
/p h3INTERFACES /h3 h3INTERNAL /h3 ul liAll company functions /li liThermo Fisher network /li /ul h3EXTERNAL /h3 ul liRegulatory Authorities (EU and non-EU) /li liClients /li /ul h3Requirements and Qualifications /h3 ul li(A) EDUCATION: DEGREE IN CHEMISTRY, PHARMACY, BIOLOGY/BIOTECHNOLOGY /li li(B) TECHNICAL SKILLS: GMP KNOWLEDGE (EU/US; JP IS A PLUS) /li liKNOWLEDGE OF STERILE MANUFACTURING PROCESSES EXPERIENCE IN FDA-APPROVED PHARMA COMPANIES /li li(C) EXPERIENCE: EXPERIENCE IN QUALITY SYSTEMS IN EMA/FDA ENVIRONMENTS (5–7 YEARS) /li li(D) LANGUAGES: ENGLISH (FLUENT) /li /ul h3SOFT SKILLS /h3 ul liLeadership and people management /li liStructured and compliance-oriented mindset /li liEffective communication and influencing skills /li liContinuous improvement mindset Competencies /li liCross-functional collaboration /li liAbility to operate in complex environments and manage priorities /li liIndependent judgment and objective decision-making /li liAbility to lead, motivate and develop team /li /ul pThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
/p /p #J-*****-Ljbffr

📌 Sr Manager, Quality System (Lazio)
🏢 Thermofisher Scientific
📍 Lazio