Quality System Manager

1 settimana fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

Thermo Fisher Scientific’s Mission is to enable our customers to make the world healthier, cleaner and safer, and the global coronavirus (COVID-19) outbreak is a powerful reminder of the importance of that Mission. In fact, Thermo Fisher is at the forefront of the global response to COVID-19. We are working with governments, agencies, industry partners and researchers globally to ensure priority access to instruments, consumables, safety supplies and other products to address the outbreak. Our efforts have been particularly focused in supporting analysis of the virus, diagnosis, personal protection, and ultimately helping in the development of new therapeutics and vaccines.

**How will you make an impact?**

You will join a newly established team responsible for cGMP mRNA-based drug production based at Monza, Italy.
Leading the start up of the mRNA-dedicated Quality Unit, you will ensure that site operations meet cGMP and regulatory compliance while respecting European and International Regulations, Corporate Standards and Clients requirements, through the guidance, coordination and control of the reporting structure.

In this role you will leverage your experience as manager to promote proper and proactive business partnership with site functions and facilitate people and organization development.

**What will you do?**

**Quality Systems & Compliance**
- Support and collaborate with Training&Quality System Team to implement the.Pharmaceutical Quality System, according withcGMP regulations and Corporate Standards
- Ensure a proactive site cGMP inspection readiness program, evaluating potential gaps, identifying action plans in collaboration with the involved functions and providing follow up
- Ensure the proper preparation, management and follow up of Regulatory Authorities and Clients inspections
- Ensure timely execution of the internal and external auditing program
- Ensure proper management of suppliers
- Ensure timely preparation of APRs

**Validation and Calibration**
- Collaborate with technical Services to ensure that equipment validation and calibration activities meets cGMP and Corporate Standards
- Ensure that production processes and cleaning validation meet cGMP and Corporate Standards through the guidance, coordination and control of the reporting structure
- Ensure that an effective and complaint change control system is in place

**How will you get here?**

**Education**
- Degree in a Scientific Area

**Experience**
- At least 10 years of experience in Pharma Operations.
- Experience in Quality Units of pharmaceutical company.
- Experience in people management and development

**Knowledge, Skills, Abilities**
- Knowledge of Sterility Assurance.
- QP nomination by AIFA and or QP elegibility
- Italian+English
- Leadership, including change management
- Team work
- Listening, negotiation and communication skills
- Strategic thinking
- Pragmatic and oriented to prioritization and results achievement

At Thermo Fisher Scientific, each one of our 100,000+ extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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