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Mitchell Wheeler
Principal Consultant / Owner, Qualitas Compliance Services, LLC Location: Waukegan, IL United States Joined: Dec 19th, 2020 |
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| Experience |
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I currently work with Qualitas Compliance Services, LLC
as Principal Consultant / Owner I have 27 years of experience working in the Biotechnology and Pharmaceutical industry. |
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Principal Consultant / Owner |
Qualitas Compliance Services, LLC
From December 2023 to Current • 3 year(s) QMS and CGMP strategy, audit readiness, FDA 483 remediation, and validation oversight |
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Principal Consultant/Owner |
Qualitas Compliance Services, LLC
From December 2023 to Current • 3 year(s) Quality Subject Matter Expert for remediation strategy and support for RCA contractor in Lincoln, Rhode Island. |
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Senior Quality Consultant |
PharmEng Technology, Inc.
From August 2023 to November 2023 • 0 year(s) UL ComplianceWire Training System Implementation and Lead Auditor for MDSAP Audit at Convatec. |
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Senior Quality Consultant |
PharmEng Technology, Inc.
From May 2020 to November 2023 • 3 year(s) Led MDSAP audits, FDA inspection readiness, and eQMS integration |
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Director - Quality Systems |
AmerisourceBergen
From August 2022 to July 2023 • 1 year(s) Managed $6.2M MasterControl rollout across 150+ sites |
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Director – Quality Systems – US Human Health |
AmerisourceBergen
From August 2022 to July 2023 • 1 year(s) Served as project lead for $6.2MM MasterControl eQMS Implementation for US Distribution and global distribution network. |
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Senior Quality Consultant |
PharmEng Technology, Inc.
From May 2020 to August 2022 • 2 year(s) Quality SME and inspection readiness support for various pharmaceutical and medical device clients. |
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Principal Consultant/Owner |
Qualitas Compliance Services, LLC
From June 2018 to April 2020 • 2 year(s) Independent quality systems consultant conducting gap analyses, audits, and QMS development for regulated industries. |
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Senior Director - Corporate Quality & Continuous Improvement |
Dohmen Life Science Services
From August 2016 to May 2018 • 2 year(s) Standardized QMS SOPs for startup, led corporate audits |
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Senior Director – Corporate Quality and Continuous Improvement |
Dohmen Life Science Services
From August 2016 to May 2018 • 2 year(s) Provided quality system compliance support and regulatory expertise to start-up company operations. |
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Senior Quality Engineering Manager |
PharMEDium Services, LLC
From April 2015 to August 2016 • 1 year(s) Oversaw Corporate QE, validation, and regulatory compliance for four 503B facilities |
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Senior Quality Engineering Manager |
AmerisourceBergen – PharMEDium Services, LLC
From April 2015 to August 2016 • 1 year(s) Senior quality system subject matter expert for 503B sterile aseptically compounded pharmaceuticals start-up operations. |
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Consultant – Quality, Compliance & Auditing |
Regulatory Compliance Associates
From December 2010 to April 2015 • 5 year(s) Assisted clients with compliance deficiencies identification and quality systems remediation using risk-based approaches. |
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Director - Quality & Regulatory |
Baxter Healthcare Corporation
From May 2010 to November 2010 • 0 year(s) Directed 137 complaint handlers on global complaint handling and MDR reporting |
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Director, Quality and Regulatory |
Baxter Healthcare Corporation
From May 2010 to November 2010 • 0 year(s) Managed Corporate Product Surveillance teams responsible for Medication Delivery and Renal Divisions' complaint handling. |
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Director Quality Operations |
Cardinal Health
From March 2004 to May 2010 • 6 year(s) Directed compliance for 19 distribution centers; oversaw recalls, supplier audits |
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Director, Quality and Regulatory |
Cardinal Health
From March 2004 to April 2010 • 6 year(s) Directed overall compliance, recall, regulatory reporting, and quality system activities of distribution centers. |
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Program Manager Internal Audit |
Abbott Laboratories
From October 1996 to March 2004 • 8 year(s) Internal Audits and Complaints for sterile and device products |
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Program Manager, Senior Compliance Auditor, Industrial Engineer |
Abbott Laboratories
From October 1996 to March 2004 • 8 year(s) Performed system-based compliance audits and managed global product complaint processes for Hospital Products Division. |
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Production Supervisor |
Abbott Laboratories
From October 1988 to October 1996 • 8 year(s) Supervised sterile injectable production, automated warehousing, batch review |
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Manufacturing / QA Supervisor |
Abbott Laboratories
From February 1988 to October 1996 • 8 year(s) Primary quality assurance representative for sterile injectable manufacturing operations and warehouse supervision. |
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