Simone Diorio

Simone Diorio Email and Phone Number

VP Quality Americas @ Baxter International Inc.
Switzerland
Simone Diorio's Location
Switzerland, Switzerland
Simone Diorio's Contact Details

Simone Diorio personal email

n/a
About Simone Diorio

- Strategic Quality leader with 30 years of proven leadership experience and a track record of achieving outstanding results in multinational pharmaceutical and medical device corporations.- Providing strategic and technical leadership in Quality and Compliance to drive the company’s business and maintain the highest quality standards, aligned with specific country regulations.- Utilizing a common-sense, data-driven approach, coupled with an extraordinary ability to assess and achieve global performance through the creation of metrics and measures that foster a strong quality culture at all organizational levels.- Serving as a liaison with FDA, MHRA, AIFA, ANVISA, TUV, BSI, and other health authorities for Quality and Compliance issues across operations, commercial, and R&D settings.- Possessing extensive knowledge of cGMP requirements and related regulatory guidance, as well as expertise in Risk Management and Quality by Design.

Simone Diorio's Current Company Details
Baxter International Inc.

Baxter International Inc.

View
VP Quality Americas
Switzerland
Website:
baxter.com
Employees:
39233
Simone Diorio Work Experience Details
  • Baxter International Inc.
    Vp Quality Americas
    Baxter International Inc.
    Switzerland
  • Baxter International Inc.
    Vp Quality Medical Products And Therapies (1700 Staff)
    Baxter International Inc. Apr 2023 - Present
    Deerfield, Illinois, Us
    Reporting to the Chief Quality Officer, responsible for the Quality of the newly formed MPT segment supporting Medication delivery, Nutrition and Advance surgery business. The responsibility includes:• Quality oversight of Baxter plants (22) globally located, producing sterilized pharma and medical device products mostly FDA approved• Lead the Product Quality team working in partnership with R&D team on the new product development as well as sustain product engineering• Leading the standardization team aiming to standardize quality and center of excellence best practices across the plants and implementing Zero Based Budget as part of standard and cost effective organization
  • Baxter International Inc.
    Vp Quality Americas
    Baxter International Inc. Jul 2021 - Jun 2023
    Deerfield, Illinois, Us
    Accountable for ensuring the successful delivery of quality strategy and operational performance across the Americas manufacturing plants (Drugs and MD).Responsible for the quality team supporting warehouses and distribution activities.Responsible for the Regulatory Affair team in Canada and LATAM.
  • Baxter International Inc.
    Vice President Quality Emea
    Baxter International Inc. Mar 2020 - May 2022
    Deerfield, Illinois, Us
  • Baxter International Inc.
    Vice President Quality Renal
    Baxter International Inc. Nov 2016 - Mar 2020
    Deerfield, Illinois, Us
  • Baxter International Inc.
    Global Director Baxter-Gambro Quality
    Baxter International Inc. Feb 2015 - Mar 2020
    Deerfield, Illinois, Us
    Reporting to the VP of Global Compliance, the position has the following responsibilities:• Quality Operation multi-plants, coming from the Gambro acquisition, located in Europe, US, Latin America and Asia Pacific producing:Hemodialysis machine, dialyzers, catheters, bloodlines sets and solutions.¬ Drive integration of the plants into the Baxter Management Quality System¬ Develop the quality strategy for the next 3 years¬ Foster change management in order to speed up the harmonization and standardization of the quality processes¬ Build up a sustaining organization through the organization inventory, people development and succession planning process¬ Drive continuous improvement process in order to leverage resources and costs across the organization¬ Develop metrics enable the organization to improve in the quality and compliance areas¬ Acting as Quality Management Responsible in the Field Corrective Action process and towards Regulatory Authorities¬ Lead a team of ~500 people
  • Baxter International Inc.
    Sr. Director Quality Emea
    Baxter International Inc. Jun 2012 - Mar 2020
    Deerfield, Illinois, Us
    Reporting to the VP of Quality EMEA, the position has the following responsibilities:• Multi-plants (Malta – Tunisia – Italy – Saudi Arabia – Turkey – 2 Plants in Switzerland) producing:o Sterile solutions for Intra-Venous and Dialysiso PVC and non-PVC films as solution containerso Form, fill and seal equipment and o Gravity & pump and administration sets¬ Drive quality and compliance standardization and harmonization.¬ Responsible for Quality Systems deployment at the facilities that report to them, independent of which products are manufactured at that site. ¬ Responsible for ensuring completion of all GMP commitments to regulatory authorities (MOH’s, TUV). ¬ Execute of the Regional Quality Strategic Plan and translate it into the appropriate tactical objectives for their respective areas of responsibility ¬ Foster the organizational development ensuring organizational inventory matching known gaps¬ Staffing, development, differentiation and succession planning for their organizations ¬ Leverage resources and costs across the organization.¬ Promote continuous improvement and active participation in development of ideas and strategies. ¬ Driving the KPIs set up at each facility and related results. ¬ Lead a team of 160 people• Quality Technical Services EMEA o Electro-medical devices repairing centers for emo and peritoneal dialysis¬ Develop the EMEA quality strategy partnering with the Technical Service function and the global Tech Service Quality organization.¬ Standardize and harmonize the quality requirements across the EMEA TS organization¬ Driving the KPIs set up and related results.
  • Baxter International Inc.
    Director Quality Engineering Emea
    Baxter International Inc. Aug 2008 - Jun 2012
    Deerfield, Illinois, Us
    Reporting to the VP of Quality EMEA, the position has the following responsibilities:• Quality R&D EMEA: ¬ Drive product reliability and predictability through the implementation and standardization of the “best industry practices” of the product development process.¬ Lead a multifunctional team in the US in order to revise the Pan-Baxter product development process for devices, integrating technical, business and risk management requirements. ¬ Forster organization changes in order to support the new process linking Baxter product families to the product design owner organization.¬ Lead a team of 40 people (Quality Engineers) across multiple locations (Belgium, Italy and Malta) to support the R&D development activities,• New business development process: ¬ Leading the quality and compliance activities during the license and acquisition process for products, facilities and services acquired in EMEA. Responsibility covers from the due diligence up to the integration of the deal into the Baxter quality system.• Program Management: ¬ Organize, lead, support and monitor programs and projects that enable quality organization in EMEA and its key partners to achieve strategic goals. Special focus has been dedicated to the continuous improve program management (Lean and 6-sigma) and Quality Engineering skill set development.¬ LIMS (Laboratory Infrastructure management System) implemented across 4 manufacturing sites in EMEA.• Sterility Assurance (SA): ¬ Develop and drive implementation for the SA strategy across EMEA sites¬ Harmonize sterilization practices, increase workforce sterilization competencies, capture and mitigate compliance risks and strive for innovative approaches (parametric release, BET and rapid test method) in cooperation with the SA US team.
  • Janssen, Pharmaceutical Companies Of Johnson And Johnson
    Director Q&C Processes And Systems, Emea/Ap
    Janssen, Pharmaceutical Companies Of Johnson And Johnson Jan 2005 - Aug 2008
    Raritan, New Jersey, Us
    Reporting to the VP of Quality EMEA, the position had the responsibility to set theStrategic Direction for Quality System processes and supporting technology, ensure the integrity, consistency, and harmonization of these processes and systems for EMEA and Asia Pacific.• Sustain and improve the processes redesign at the current standard of compliance. Partnering with European IT to translate the processes into a common electronic system and deploy at the site level.• Responsible for the Global LIMS implementation.• Responsible for CSV methodology alignment and deployment.• Regional leader for the Quality Risk Management implementation.• Provide leadership for Q&C enterprise-wide projects, including resource planning, prioritization, project leadership and management, metrics and scorecards.
  • Janssen, Pharmaceutical Companies Of Johnson And Johnson
    Quality Assurance/Qualified Person
    Janssen, Pharmaceutical Companies Of Johnson And Johnson Jan 2002 - Dec 2004
    Raritan, New Jersey, Us
    Reporting to the VP of Quality EMEA, the position had the following responsibilities:• Establish a long term strategic plan to drive the Portuguese plant into the FDA compliance status• Managing a team of 40 people and responsible for the Quality Operations, Quality Control, Validation and Computer System Validation’s group• Qualified Person • Responsible for New Product Introduction
  • Janssen, Pharmaceutical Companies Of Johnson And Johnson
    Quality Control Manager
    Janssen, Pharmaceutical Companies Of Johnson And Johnson Jul 2000 - Dec 2001
    Raritan, New Jersey, Us
    • Managing a team of 35 people; responsibilities include:¬ Chemical and Development, Microbiological and Incoming labs and for the New Product Introduction process at QC level ¬ Managing pre- & post-approval FDA audits for QC dept.
  • Janssen, Pharmaceutical Companies Of Johnson And Johnson
    International Development Assignment
    Janssen, Pharmaceutical Companies Of Johnson And Johnson Jul 1999 - Jul 2000
    Raritan, New Jersey, Us
    Exposure to FDA regulations through:• Co-operate with Compliance group to gain experience on FDA audit - Process concerning pre approval inspection (PAI) of 7 products moved and scaled up at Gurabo plant• Working with the QA Stability and Development group in order to understand US quality system related FDA/GMP compliance
  • Janssen, Pharmaceutical Companies Of Johnson And Johnson
    Chemical Lab Supervisor
    Janssen, Pharmaceutical Companies Of Johnson And Johnson Apr 1995 - Jul 1999
    Raritan, New Jersey, Us
    • Responsible for a group of 9 people working on the raw material and half/finished and stability products• Responsible for insuring FDA quality and compliance level in the lab

Simone Diorio Skills

Gmp Quality Assurance Quality System Pharmaceutical Industry Quality Control Quality Management Regulatory Affairs Continuous Improvement Project Management Strategy Biotechnology Clinical Development Fda Gmp Compliance Operational Excellence People Development Training Process Optimization Innovation Management Sales Effectiveness Pharmaceutical Sales Market Access Oncology

Simone Diorio Education Details

  • “La Sapienza”- University Of Rome
    “La Sapienza”- University Of Rome
    Pharmaceutical Sciences
  • “La Sapienza”- University Of Rome
    “La Sapienza”- University Of Rome
    Pharmaceutical Sciences

Frequently Asked Questions about Simone Diorio

What company does Simone Diorio work for?

Simone Diorio works for Baxter International Inc.

What is Simone Diorio's role at the current company?

Simone Diorio's current role is VP Quality Americas.

What is Simone Diorio's email address?

Simone Diorio's email address is sd****@****jnj.com

What schools did Simone Diorio attend?

Simone Diorio attended “la Sapienza”- University Of Rome, “la Sapienza”- University Of Rome.

What skills is Simone Diorio known for?

Simone Diorio has skills like Gmp, Quality Assurance, Quality System, Pharmaceutical Industry, Quality Control, Quality Management, Regulatory Affairs, Continuous Improvement, Project Management, Strategy, Biotechnology, Clinical Development.

Who are Simone Diorio's colleagues?

Simone Diorio's colleagues are Andrea Flores, Rayan Abdulrahman, Kunal Desai, Eugenia Mora, Hanna Seume, Olga Pryanikova, Azlan Yandiy.

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