Quality Compliance Senior Manager

4 settimane fa


Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

Job Summary
Thermo Fisher Scientific Inc. is seeking a highly motivated Quality Compliance Senior Manager to join our team in Italy. As a Quality Compliance Senior Manager, you will play a key role in ensuring site operations meet cGMP and regulatory compliance while maintaining our commitment to exceptional quality standards.

Responsibilities
Support and facilitate the implementation of the Pharmaceutical Quality System, ensuring compliance with cGMP regulations and Corporate Standards
Proactively assess site cGMP inspection readiness, identify potential gaps, and collaborate with relevant functions to develop action plans
Lead the preparation, management, and follow-up of Regulatory Authorities and Clients inspections
Lead all aspects of the execution of internal and external auditing programs
Provide guidance and coordination to ensure production processes and cleaning and equipment validation meet cGMP and Corporate Standards

Requirements
MsC or higher diploma in chemistry, biotech, or pharmaceutical fields
Minimum of 10 years of experience in Pharma Operations, with a focus on QA leadership
Experience in Quality Units of a pharmaceutical company, demonstrating a strong compliance background
Knowledge of Sterility Assurance is crucial
Experience in people management and development
Fluent in English and Italian
Excellent leadership abilities, including the capacity to lead change, adopt a forward-thinking approach, and cultivate a collaborative team environment
Excellent listening, negotiation, and communication skills
Pragmatic and demonstrates a focus on achieving desired outcomes

About Us
Thermo Fisher Scientific Inc. is an Equal Opportunity Employer. We value diversity and inclusion in our workforce, and 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.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.



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