Quality Assurance Manager
2 giorni fa
At Thermo Fisher Scientific, we are the world leader in serving science with a revenue of approximately $40 billion. Our mission is to enable our customers to make the world healthier, cleaner and safer.
We support our customers by accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies. Our global organization delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands.
This role ensures that site operations meet cGMP and regulatory compliance while respecting European and International Regulations, Corporate Standards and Clients requirements. The successful candidate will guide, coordinate and control the reporting structure to promote proper business partnership with site functions, facilitate people and organization development, and ensure Quality Systems & Compliance.
Key Responsibilities:
• Support and facilitate the implementation of the Pharmaceutical Quality System ensuring timely updating to cGMP regulations and Corporate Standards
• Ensure proactive site cGMP inspection readiness program evaluating potential gaps, identifying action plans in collaboration with involved functions and providing follow up
• Ensure proper preparation, management and follow up of Regulatory Authorities and Clients inspections
• Execute internal and external auditing program ensuring timely execution
• Manage suppliers effectively
• Prepare APRs on time
• Ensure production processes and cleaning validation meet cGMP and Corporate Standards through guidance, coordination and control of the reporting structure
• Organization Management: Manage performance and development of collaborators to ensure achievement of personal and site goals as well as a great place to work environment
Requirements:
- MsC or higher diploma in chemistry, biotech, or pharmaceutical fields
- At least 10 years of experience in Pharma Operations as QA leader
- Experience in Quality Units of pharmaceutical company, with a focus on compliance
- Knowledge of Sterility Assurance
- QP nomination by AIFA (optional)
- People management and development experience
- Fluent English and Italian language skills
- Leadership skills, including change management
- Team work attitude
- Listening, negotiation and communication skills
- Strategic thinking
- Pragmatic and oriented to prioritization and results achievement
The estimated salary for this role is around $120,000 per year, depending on location and experience. As 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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