Mark Rimbergas
Associate Director Quality Assurance at Arcus Biosciences- Claim this Profile
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Topline Score
Bio
Cynthia Gray
Mark is a highly competent QARA professional. He is the consumate professional and very team oriented. He is highy collaborative and effective in his communication skills. Mark was a strong contributor to the Global QARA Training team at GE.
Joseph Consoli
As Validation Engineer at Sysmex, I have worked closely with Mark on several projects he headed as Capa board chair. I have found him to be extremely competent and professional. He is an excellent facilitator and possesses deep regulatory and quality knowledge. With his far reaching skills and work ethics, he would be an asset to any organization.
Cynthia Gray
Mark is a highly competent QARA professional. He is the consumate professional and very team oriented. He is highy collaborative and effective in his communication skills. Mark was a strong contributor to the Global QARA Training team at GE.
Joseph Consoli
As Validation Engineer at Sysmex, I have worked closely with Mark on several projects he headed as Capa board chair. I have found him to be extremely competent and professional. He is an excellent facilitator and possesses deep regulatory and quality knowledge. With his far reaching skills and work ethics, he would be an asset to any organization.
Cynthia Gray
Mark is a highly competent QARA professional. He is the consumate professional and very team oriented. He is highy collaborative and effective in his communication skills. Mark was a strong contributor to the Global QARA Training team at GE.
Joseph Consoli
As Validation Engineer at Sysmex, I have worked closely with Mark on several projects he headed as Capa board chair. I have found him to be extremely competent and professional. He is an excellent facilitator and possesses deep regulatory and quality knowledge. With his far reaching skills and work ethics, he would be an asset to any organization.
Cynthia Gray
Mark is a highly competent QARA professional. He is the consumate professional and very team oriented. He is highy collaborative and effective in his communication skills. Mark was a strong contributor to the Global QARA Training team at GE.
Joseph Consoli
As Validation Engineer at Sysmex, I have worked closely with Mark on several projects he headed as Capa board chair. I have found him to be extremely competent and professional. He is an excellent facilitator and possesses deep regulatory and quality knowledge. With his far reaching skills and work ethics, he would be an asset to any organization.
Credentials
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Oxford Executive Leadership Programme
Saïd Business School, University of OxfordMay, 2020- Nov, 2024 -
Lean Six Sigma Green Belt
AndersonBreconJun, 2012- Nov, 2024 -
ASQ Certified Medical Device Auditor
ASQ - World HeadquartersSep, 2012- Nov, 2024 -
ASQ Certified Quality Auditor
ASQ - World HeadquartersNov, 2011- Nov, 2024
Experience
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Arcus Biosciences
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United States
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Biotechnology
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300 - 400 Employee
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Associate Director Quality Assurance
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Sep 2021 - Present
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Novartis Gene Therapies
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United States
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Biotechnology Research
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700 & Above Employee
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Associate Director, Global Compliance
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Sep 2020 - Aug 2021
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Associate Director, Global Compliance
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Apr 2020 - Aug 2020
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Senior Manager, Supplier Quality Assurance
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Oct 2019 - Apr 2020
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Manager, Supplier Quality Assurance
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Dec 2018 - Oct 2019
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Catalent Pharma Solutions
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Global Supplier Auditor
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Feb 2016 - Dec 2018
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Compliance Specialist & Lead Supplier Auditor
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Mar 2014 - Feb 2016
Maintain the effectiveness of the Quality System and oversee the Woodstock site Supplier Audit program. Ensure Catalent is protected from using unacceptable Suppliers by adhering to audit schedule, conducting thorough audits, supporting R&D, and ensuring the Approved Supplier List (ASL) is current. Responsible for providing metrics for Corporate Review, Management Review, and Annual Product Reviews. As Lead Auditor train and mentor associates new to the program. Implement site level Supplier Quality Risk Management program. Lead cross functional Supplier Review Board.
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PCI Pharma Services
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Systems Compliance Specialist
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Feb 2011 - Mar 2014
Manage Divisional Change Control process. Manage Divisional Nonconforming Material process. Manage the Divisional Calibration process. Member of the Internal Audit team. Supply Chain Auditor. Write/Execute Process Validations. Monitor Environmental Conditions. Certified Lean Six Sigma Green Belt. Manage Divisional Change Control process. Manage Divisional Nonconforming Material process. Manage the Divisional Calibration process. Member of the Internal Audit team. Supply Chain Auditor. Write/Execute Process Validations. Monitor Environmental Conditions. Certified Lean Six Sigma Green Belt.
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Sysmex America, Inc.
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Quality Systems Analyst
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Oct 2008 - Feb 2011
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GE HealthCare
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United States
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Hospitals and Health Care
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700 & Above Employee
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Product Surveillance Leader
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Mar 2007 - Oct 2008
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W. L. Gore & Associates
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United States
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Medical Device
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700 & Above Employee
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Production/Product Surveillance Specialist
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2004 - 2007
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Abbott
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United States
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Hospitals and Health Care
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700 & Above Employee
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Various QA/QC/MFG
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Jun 1996 - 2004
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Education
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2008 - 2012
Northwestern University
Master's Degree, Medical Informatics -
1991 - 1996
Benedictine University
Bachelor of Science, Biology
Community
