- To embrace the 4-I values of Integrity, Intensity, Innovation and Involvement by role modeling the values.
- To set strategy and direction for Quality Operations department to ensure continuous improvements regarding the cGMP compliance standards and to accomplish compliance in the most efficient way. Advise quality top management on issues that may affect the site and/or Thermo Fisher Scientific as a whole.
- To recruit, retain and develop an impactful Quality Operations Team, acting as a role model leader for the entire organization by creating positive work environments and inspiring a culture of feedback and inclusion
- To be responsible for product quality, compliance, conformance to quality requirements and specifications, and conformance to customer quality requirements. To Lead work teams such as quality on the floor, batch release, customer support.
- To drive accountability around site quality metrics across all functions and act as key contributor towards financial performance metrics and customer scorecard metrics.
- To collaborate in handling customer relationships via proactive risk mitigation, and effective communication
- To act as a Site Qualified Person, also leading and supporting the QP network in the site.
- To collaborate with industry-driving customers to design and recommend a proactive approach to meeting future industry and regulatory needs.
- To represent Quality Assurance in all Regulatory and Customer Inspections as well as compliance issues and on Quality Governance committees.
- To ensure efficient operations to support commitments to customers regarding product delivery and project results.
- To ensure adherence of Manufacturing and Packaging to regulatory requirements. Provide systems to maintain compliance with these requirements.
- To remain current in relevant worldwide regulations pertaining to manufacturing quality assurance. This includes working with key customers to recognize future customer and regulatory expectations.
- Create development plans for high potential colleagues and ensure department's growth and improvement over time
- To interact, negotiate and persuade management within different organizations, including internal organizations, customers and other external entities. The job holder must effectively blend the compliance of corporate quality standards with the quality requirements of customers.
- Bachelor's degree in Physical Sciences, Engineering or related field required.
- 15+ years of cGMP experience in the pharmaceutical industry.
- Eligible to act as QP in Italy
- Sterile manufacturing experience is considered required for the role. CDMO experience is a strong plus.
- 10+ years in a leadership role, ideally in a international environment.
- Strong communication, influencing and change leadership skills.
- Ability to navigate successfully in a complex matrix organization and a complex business model (multiple lines/multiple products/ multiple customers).
- Analytical attitude and Critical thinking.
- Process orientation and optimization.
- Sense of urgency in a high intensity environment.
- Advanced communication and presentation skills; confidence in working directly with a wide range of international customers, senior internal stakeholders and regulators.
- Strong decision making skills.
- English and Italian fluency.
-
Supervisor, Quality Operations
1 settimana fa
Thermo Fisher Scientific Monza, ItaliaCustomers globally rely on our extensive range of products and services— · from life-saving medicines to lab essentials to next-generation instruments. Our Operations team leverages our PPI (Practical Process Improvement Business System) to manufacture and produce these products ...
-
Supervisor, Quality Operations
5 giorni fa
Thermo Fisher Scientific Monza, ItaliaAssicura che le attività relative ai lotti prodotti nell'Unità assegnata siano svolte in conformità con le specifiche dei prodotti, le normative vigenti, le procedure aziendali e i corporate standard, supportando la Persona Qualificata nel giudizio di conformità sui lotti prodott ...
-
Supervisor, Quality Operations
4 ore fa
Thermo Fisher Scientific Monza, ItaliaThermo Fisher Scientific, world leader in serving science sta reperendo per il sito di Monza DPD un Supervisor per la propria struttura di Quality Operations. · **SCOPO DELLA POSIZIONE/RESPONSABILITÀ**: · Alle dipendenze del Quality Operations Sr Manager & Qualified Person, trami ...
-
Quality Operations Supervisor
1 settimana fa
Thermo Fisher Scientific Monza, ItaliaLo stabilimento produttivo di Monza è un centro di eccellenza globale per quanto riguarda le produzioni di farmaci sterili conto terzi. Entrerai a far parte di un team di circa 2000 colleghi in un ambiente giovane, dinamico e fortemente orientato all'obiettivo. Con un fatturato d ...
-
Quality Operations Supervisor
3 giorni fa
Thermo Fisher Scientific Monza, ItaliaLo stabilimento produttivo di Monza è un centro di eccellenza globale per quanto riguarda le produzioni di farmaci sterili conto terzi. Entrerai a far parte di un team di circa 2000 colleghi in un ambiente giovane, dinamico e fortemente orientato all''obiettivo. Con un fatturato ...
-
Supervisor, Quality Operations
4 giorni fa
Thermo Fisher Scientific Monza, Italia A tempo pienoThermo Fisher Scientific, world leader in serving science sta reperendo per il sito di Monza DPD un Supervisor per la propria struttura di Quality Operations. · SCOPO DELLA POSIZIONE/RESPONSABILITÀ: · Alle dipendenze del Quality Operations Sr Manager & Qualified Person, tramite ...
-
Supervisor, Quality Operations
1 giorno fa
Thermo Fisher Scientific Inc. Monza, ItaliaJob Description Thermo Fisher Scientific, world leader in serving science sta reperendo per il sito di Monza DPD un Supervisor per la propria struttura di Quality Operations. · SCOPO DELLA POSIZIONE/RESPONSABILITÀ: Alle dipendenze del Quality Operations Sr Manager & Qualified Per ...
-
Director, Quality Operations
1 settimana fa
Thermo Fisher Scientific Monza, ItaliaAs part of the team at Thermo Fisher Scientific, we do meaningful work, that makes a positive impact on a global scale Join our 120,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You'll find th ...
-
Operational Quality Machining
1 settimana fa
Bosch Group Villasanta, Italiadell'azienda · **At Bosch, we care; for you, our business, and our environment.** · Let's turn visions into reality. At Bosch, we shape the future by inventing high-quality technologies and services that spark enthusiasm and enrich people's lives. Our areas of activity are every ...
-
Mrna Quality Operation Specialist
1 settimana fa
Thermo Fisher Scientific Monza, ItaliaThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving so ...
-
Quality Operations Associate
1 settimana fa
sennder Milano, Italiasennder is Europe's leading digital freight forwarder. In a traditional industry, we are moving fast to digitise and automate all road logistics processes. We are a growing team looking for a Quality Operations Associate to help us on our journey to revolutionise road freight log ...
-
Quality Operations Associate
1 settimana fa
sennder Milano, Italiasennder is Europe's leading digital freight forwarder. In a traditional industry, we are moving fast to digitise and automate all road logistics processes. We are a growing team looking for a Quality Operations Associate to help us on our journey to revolutionise road freight log ...
-
Quality Operations Associate
1 settimana fa
sennder Milano, Italia**_Quality Operations Associate_** · **sennder is Europe's leading digital freight forwarder. In a traditional industry, we are moving fast to digitise and automate all road logistics processes. We are a growing team looking for a Quality Operations Associate to help us on our jo ...
-
Quality Operations Associate
1 settimana fa
sennder Milano, Italia**_Quality Operations Associate - L.68/99_** · **sennder is Europe's leading digital freight forwarder. In a traditional industry, we are moving fast to digitise and automate all road logistics processes. We are a growing team looking for a Quality Operations Associate to help us ...
-
Director, Quality Operations
4 giorni fa
Thermo Fisher Scientific Monza, Italia A tempo pieno: To embrace the 4-I values of Integrity, Intensity, Innovation and Involvement by role modeling the values. · To set strategy and direction for Quality Operations department to ensure continuous improvements regarding the cGMP compliance standards and to accomplish compliance ...
-
Stage Pace Operations and Data Quality Assistant
5 giorni fa
TD SYNNEX San Giuliano Milanese, ItaliaSupporting PACE team in execution and analysis - Data quality and CRM focus · **Responsibilities**: · - To support all aspects of the PACE activity to help the business achieve both team and company targets · - Learn how to priorities own tasks to ensure agreed deadline or SLA is ...
-
Quality On The Floor Specialist
2 giorni fa
Thermo Fisher Scientific Monza, ItaliaThermo Fisher Scientific, World leader in Serving Science, è alla ricerca di un Sr QA Technician di supporto all'area Quality Operations. · Le mansioni principali sono: · In base alle indicazioni del Quality on the Floor Team Leader, del Quality Operation Supervisor e del Quality ...
-
Quality On The Floor Specialist
1 settimana fa
Thermo Fisher Scientific Monza, Italia A tempo pienoIn base alle indicazioni del Quality on the Floor Team Leader, del Quality Operation Supervisor e del Quality Operations Manager, la risorsa si occupa della Batch Record Review dei lotti GMP nel rispetto delle procedure aziendali, degli standard di qualità e delle normative vigen ...
-
Quality On The Floor Specialist
4 giorni fa
Thermo Fisher Scientific Monza, Italia A tempo pienoIn base alle indicazioni del Quality on the Floor Team Leader e del Quality Operations Manager, la risorsa si occupa della Batch Record Review dei lotti GMP nel rispetto delle procedure aziendali, degli standard di qualità e delle normative vigenti (leggi, norme GMP, FDA, etc.) e ...
-
Quality On The Floor Specialist
5 giorni fa
Thermo Fisher Scientific Monza, ItaliaIn base alle indicazioni del Quality on the Floor Team Leader, del Quality Operation Supervisor e del Quality Operations Manager, la risorsa si occupa della Batch Record Review dei lotti GMP nel rispetto delle procedure aziendali, degli standard di qualità e delle normative vigen ...
Director, Quality Operations - Monza, Italia - Thermo Fisher Scientific
Descrizione
Job Description
As part of the team at Thermo Fisher Scientific, we do meaningful work, that makes a positive impact on a global scale Join our 120,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You'll find the resources here to achieve your career goals and enable the future of scientific advances. Our work enables the groundbreaking biopharma research, advances precision medicine and supports the innovation of advanced materials, such as next-gen batteries and semiconductors.
Position summary
The Director, Quality Operations will provide quality oversight to our Commercial (DPS) and Pharmaceutical Development Services (PDS) sterile operations ensuring full compliance of quality, customer, and regulatory requirements for all the filling lines, visual inspection, and packaging.
Overall Team: 125 colleagues
Key Responsibilities:
Requirements:
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.