Quality Compliance Senior Manager

3 ore fa

Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno
{"title": "Quality Compliance Senior Manager", "content": "Job Summary

We are seeking a highly experienced Quality Compliance Senior Manager to join our team at Thermo Fisher Scientific. In this role, you will be responsible for ensuring compliance with cGMP regulations and Corporate Standards, as well as leading the preparation and management of Regulatory Authorities and Clients inspections.

Key Responsibilities
  • Support and facilitate the implementation of the Pharmaceutical Quality System
  • Proactively assess site cGMP inspection readiness and identify potential gaps
  • 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.

", "lang_code": "en-US"}

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