PDS Quality Senior Manager
4 settimane fa
Thermo Fisher Scientific Inc. is a world leader in serving science, with annual revenue of over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer.
We are seeking a Quality Operations Leader to join our PDS business unit at our Monza site.
Main Responsibilities:- Ensure Quality Operations meets cGMP and regulatory compliance with respect for defined methods, current regulations, and corporate quality standards.
- Promote accurate and proactive business partnership with site functions and facilitate people and organization development.
- Lead the reporting structure (Quality On The Floor staff and Quality Operations staff) ensuring proper review of production manufacturing and documentation, CoAs, and possible investigations in full compliance with cGMPs, registration documentation, and clients' requirements.
- Support the Qualified Person in product disposition and issues assessment.
- Ensure respect for corporate quality standards through auditing and overseeing the application of procedures relative to the area managed.
- Guarantee surveillance of on-shift production activities (overlooking and fit&finish in production area) to proactively increase the Quality Culture within the Departments.
- Leadership skills and ability to manage complex projects.
- Prioritization skills.
- Expertise in pharmaceutical companies, exposure to clients, and regulatory matters is crucial.
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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