Julian Fiori

• Establish the strategy and ensure the alignment of the plant's Quality Systems with local and corporate requirements.
• Establish, implement, manage & maintain the standards and quality systems for ensuring that the organization's compliance with all FDA regulatory requirements.
• Prepares and successfully completes internal and external Quality Audit Plan.
• Identifies and monitor quality indicators and data to identify potential trends and risks to patient safety, compliance, data integrity or to the business and promote improvements.
• Member of the Americas Quality Leadership team
• Sponsor of Americas Quality Risk management
• Host Internal and regulatory inspections and audits
• Ensures all personnel performing quality testing within the quality lab and on the production floor are trained and qualified.
• Assesses training needs of staff and ensures execution of training.
• Business Performance Lead for Americas Region

· Responsible Pharmacist for Astrazeneca operation in Argentina

· Ensured transportation, storage, and delivery of products in accordance with licensing requirements and local/company regulations.

· Supported business operations by managing supply of both locally produced and imported products.

· Collaborated with clinical and regulatory teams to facilitate successful product launches.

· Worked closely with clinical, regulatory, and medical teams to introduce new products to the market.

· Oversaw and maintained the internal audit program to ensure compliance and continuous improvement.

• Host regulatory and customer audits.
• Hosts periodic customer visits; primary contact for quality and regulatory related communications with customer
• Assure Quality on manufactured and distributed products in the markets supplied (LATAM)

• Establish the Quality guidelines for the Oncology line
• Internal Auditor
• Support design of oncology site commission

• Supervise production processes and release locally produced and imported products to the market.
• Release of local and imported products
• Internal qualified auditor

• Head of Quality Control of the Physicochemical and Microbiological laboratory.
• Developed and implemented quality control processes to ensure compliance with regulatory standards.