Quality Compliance Sr Manager in Monza, Italy

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Are you ready to take on a unique opportunity with Thermo Fisher Scientific Inc., the world leader in serving science? We are seeking a highly motivated Quality Compliance Sr Manager to join our team in Monza, Province of Monza and Brianza, Italy. With annual revenue of approximately $40 billion, our mission is to enable our customers to make the world healthier, cleaner, and safer. As a Quality Compliance Sr 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

• Develop a culture of collaboration and partnership with site functions

• Drive people and organization development, leading performance and development of team members

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

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.

Join us!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.