Quality Compliance Sr Manager

Thermo Fisher Scientific; Monza; In loco; EUR 70.000 - 100.000; Tempo pieno

Descrizione del lavoro

A leading company in the pharmaceutical sector seeks a Quality Assurance Leader in Monza, Italy. The successful candidate will ensure compliance with cGMP regulations, lead inspections, and foster team development. This role requires significant experience in Pharma Operations and a strong academic background.

Competenze

• Minimum 10 years of experience in Pharma Operations with focus on QA leadership.
• Experience in Quality Units of a pharmaceutical company with strong compliance background.
• Fluency in English and Italian required.

Mansioni

• Support implementation of the Pharmaceutical Quality System to ensure compliance.
• Manage inspections and audit programs for regulatory authorities.
• Drive culture of collaboration and development within the team.

Conoscenze

Leadership

Communication

Negotiation

Listening

Team Development

Formazione

MsC or higher diploma in chemistry, biotech, or pharmaceutical fields

Descrizione del lavoro

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• 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.