Michele Simone

FAQ About Michele Simone

• What is Michele Simone's address?

  Michele Simone is located at
  Ticino, Ticino, Argentina

• What is Michele Simone's job title?

  Michele Simone is a
  Quality professional with 30 years experience in the pharma/biopharma industry. I am a Biologist and Clinical Pathologist by education. "Qualified Person" according to Directive 2001/83/EC. I am currently acting as Director of Corporate Quality Risk Management & Continual Improvement for the Bracco Group, an international group active in the healthcare sector, and a global leader in diagnostic imaging. I have 30 years’ experience in the pharma/biopharma industry, and I hold different sites and corporate Quality roles in different organizations, including but not limited to Serono, Janssen Cilag, J&J, Novartis V&D and Merck. I am an active member of PDA since 2004. I am part of PDA Chapter Italy - Board of Directors since 2014. Iwill act as Regulatory Watch and Inspections Trends Leader in the current 2024-25 mandate. I am currently a member of PDA Regulatory Affairs and Quality Advisory Board (RAQAB): the mission of the PDA RAQAB is to serve the PDA membership by influencing scientific-based regulations and providing interpretation on quality and regulatory issues affecting development, manufacturing, and control of healthcare products. This encompasses many areas including FDA, EMA other global Regulatory Authorities and/or applicable bodies. I am also the Chair of the PDA IG “Quality System”. I had been part of the PDA Task Force “Remote Audits and Inspections” and I contributed to issue the PDA Point of Consider – Remote Audits and to review the PDA Point of Consider – Remote Inspections. I often serve as presenter, chair and moderator at major conferences on quality topics. I have solid knowledge of GMP and ISO requirements, extensive experience organizing/leading competent authority inspections, including FDA, and preparing/conducting GMP training courses also for Training Consultancy firms. In-depth QA and GxP experience in drug products including parenterals, medical device and vaccines manufacturing and control process. Integrity, honesty and openess with others. Genuine caring for people. Good in coaching, development, guidance and encouragement to help others reach their full potential. Bracco

• What industry does Michele Simone currently work in?

  Michele Simone currently works in the
  Bracco

• What is Michele Simone's area of expertise?

  Michele Simone specializes in
  Quality professional with 30 years experience in the pharma/biopharma industry. I am a Biologist and Clinical Pathologist by education. "Qualified Person" according to Directive 2001/83/EC. I am currently acting as Director of Corporate Quality Risk Management & Continual Improvement for the Bracco Group, an international group active in the healthcare sector, and a global leader in diagnostic imaging. I have 30 years’ experience in the pharma/biopharma industry, and I hold different sites and corporate Quality roles in different organizations, including but not limited to Serono, Janssen Cilag, J&J, Novartis V&D and Merck. I am an active member of PDA since 2004. I am part of PDA Chapter Italy - Board of Directors since 2014. Iwill act as Regulatory Watch and Inspections Trends Leader in the current 2024-25 mandate. I am currently a member of PDA Regulatory Affairs and Quality Advisory Board (RAQAB): the mission of the PDA RAQAB is to serve the PDA membership by influencing scientific-based regulations and providing interpretation on quality and regulatory issues affecting development, manufacturing, and control of healthcare products. This encompasses many areas including FDA, EMA other global Regulatory Authorities and/or applicable bodies. I am also the Chair of the PDA IG “Quality System”. I had been part of the PDA Task Force “Remote Audits and Inspections” and I contributed to issue the PDA Point of Consider – Remote Audits and to review the PDA Point of Consider – Remote Inspections. I often serve as presenter, chair and moderator at major conferences on quality topics. I have solid knowledge of GMP and ISO requirements, extensive experience organizing/leading competent authority inspections, including FDA, and preparing/conducting GMP training courses also for Training Consultancy firms. In-depth QA and GxP experience in drug products including parenterals, medical device and vaccines manufacturing and control process. Integrity, honesty and openess with others. Genuine caring for people. Good in coaching, development, guidance and encouragement to help others reach their full potential.

• Which languages does Michele Simone speak? 

  Michele Simone speaks the following languages:
  No languages available.

• Which industries has Michele Simone previously worked in?   

  Michele Simone has prior experience in the following industries:
  Bracco , Merck , Merck , Nerviano Medical Sciences , Nerviano Medical Sciences , Janssen Cilag A Subsidiary Company Of Johnson And Johnson , Novartis , Gpsg Emea Unit Of Johnson And Johnson , Janssen Cilag A Subsidiary Company Of Johnson And Johnson , Industria Farmaceutica Serono , Universita Degli Studi Di Bari

• What is Michele Simone’s work experience?  

  Michele Simone has the following professional experience:
  Bracco , Bracco , Merck , Merck , Nerviano Medical Sciences , Nerviano Medical Sciences , Janssen Cilag A Subsidiary Company Of Johnson And Johnson , Novartis , Gpsg Emea Unit Of Johnson And Johnson , Janssen Cilag A Subsidiary Company Of Johnson And Johnson , Industria Farmaceutica Serono , Universita Degli Studi Di Bari .

• How can I find Michele Simone on LinkedIn?  

  You can view Michele Simone’s
  LinkedIn profile at LinkedIn URL.

• What are Michele Simone’s work email addresses?  

  Michele Simone’s work email addresses are
  [email protected] .

• What company does Michele Simone work for?  

  Michele Simone works at
  Bracco