Sr Manager, Qa Compliance

5 giorni fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

Thermo 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 sophisticated analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them.
Our global organization of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
In this role, 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.
Promote proper and proactive business partnership with site functions.
Facilitate people and organization development
Quality Systems & Compliance
- Support and facilitate the implementation of the Pharmaceutical Quality System, ensuring timely updating to the cGMP 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
- Ensure that production processes and cleaning validation meet cGMP and Corporate Standards through the guidance, coordination and control of the reporting structure
- Organization Management
- Manages performance and development of collaborators to ensure achievement of personal and site goals as well as a "great place to work" environment
**How will you get there?
**
- MsC or higher diploma in chemistry, biotech, or pharmaceutical fields
- At least 10 years of experience in Pharma Operations as QA leader.
- Experience in Quality Units of pharmaceutical company, with a focus on compliance
- Knowledge of Sterility Assurance.
- QP nomination by AIFA (optional)
- Experience in people management and development
- Fluent English and Italian
- Leadership skills, including change management
- Team work attitude
- Listening, negotiation and communication skills
- Strategic thinking
- Pragmatic and oriented to prioritization and results achievement
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.

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