Sr Manager, Quality System

Work Schedule

Flex Shifts 40 hrs/wk

Environmental Conditions

Office

Job Description

As 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.

PURPOSE OF THE ROLE / RESPONSIBILITIES:

Ensure 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.

Ensure 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.

Act as a reference point for Quality Governance and support senior management in data- and risk-based decision-making.

Quality System Governance (QMS) & Oversight

· Ensure governance, effectiveness and compliance of the QMS, maintaining state of control and continuous improvement

· Ensure independent and unbiased oversight of GMP systems and processes, with proactive risk identification

· Lead Quality Management Review and Quality Council, ensuring KPI monitoring and trend analysis

· Define, monitor and ensure achievement of quality KPIs, supporting management decision-making

GMP Procedures and Documentation

· Ensure management, review, approval and distribution of GMP documentation in compliance with EU/US GMP and corporate standards

· Ensure proper management and distribution of controlled copies across departments

· Ensure SOP updates in line with regulatory requirements, including periodic review planning

· Ensure proper management and issuance of analytical specifications

· Ensure execution of gap assessments vs corporate standards, including feedback collection

· Ensure periodic review of gaps and support functions in their closure

· Monitor and ensure achievement of KPIs related to procedures and corporate standards

· Ensure maintenance of qualification status (facilities, equipment, PPQ, cleaning) and VMP update

Change Control

· Ensure proper management of Change Control system applied to site processes and systems

· Ensure management and facilitation of Change Control Board

· Ensure quality and regulatory impact assessment of changes

· Monitor and ensure achievement of Change Control KPIs

Training

· Ensure effective onboarding process for new hires

· Ensure management and execution of GMP training

· Ensure update of training curricula across departments

· Ensure identification and assessment of current and future training needs

· Promote innovative training methods (digitalization, augmented reality)

· Monitor and ensure achievement of training KPIs

Data System Administration (DSA)

· Ensure compliance of GMP electronic systems in line with Data Integrity principles

· Ensure access management and segregation of duties

· Ensure periodic audit trail review

· Ensure data backup management

· Supervise user access and system parameters

· Ensure compliance of computerized systems in manufacturing and laboratory

· Ensure controlled management of system changes Computer System Validation (CSV)

· Ensure all GxP computerized systems are validated and maintained in control per GAMP 5, Annex 11, 21 CFR Part 11

· Define and maintain validation strategy (CSV Master Plan)

· Oversee Risk Assessment, IQ/OQ/PQ and periodic review

· Ensure proper management of changes to validated systems

· Ensure completeness and traceability of validation documentation

· Ensure integration between CSV and Data Integrity

· Support audits, inspections and regulatory activities

· Monitor KPIs related to computerized systems compliance Competency Development & Corporate Alignment

· Ensure continuous professional development of team and QMS functions

· Promote participation in Corporate Communities of Practice

· Foster knowledge sharing and alignment with global standards

EHS DUTIES & RESPONSIBILITIES:

Refer to Art. 19 of Legislative Decree 81/08 and subsequent amendments – Supervisor duties.

Sovraintendono 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.81/08 e D.Lgs. 152/06). 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.

I Preposti hanno la responsabilità di garantire che tutti i dipendenti operino secondo procedure ed istruzioni operative chiare ed adeguate, in un ambiente di lavoro sicuro e nel rispetto dell’ambiente, riferendo ai livelli gerarchicamente superiori le eventuali condizioni di lavoro che presentino rischi non correttamente valutati.

INTERFACES

INTERNAL

· All company functions

· Thermo Fisher network

EXTERNAL

· Regulatory Authorities (EU and non-EU)

· Clients

Requirements and Qualifications

(A) EDUCATION: DEGREE IN CHEMISTRY, PHARMACY, BIOLOGY/BIOTECHNOLOGY

(B) TECHNICAL SKILLS: GMP KNOWLEDGE (EU/US; JP IS A PLUS)

KNOWLEDGE OF STERILE MANUFACTURING PROCESSES EXPERIENCE IN FDA-APPROVED PHARMA COMPANIES

(C) EXPERIENCE: EXPERIENCE IN QUALITY SYSTEMS IN EMA/FDA ENVIRONMENTS (5–7 YEARS)

(D) LANGUAGES: ENGLISH (FLUENT)

SOFT SKILLS

· Leadership and people management

· Structured and compliance-oriented mindset

· Effective communication and influencing skills

· Continuous improvement mindset Competencies

· Cross-functional collaboration

· Ability to operate in complex environments and manage priorities

· Independent judgment and objective decision-making

· Ability to lead, motivate and develop team