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A life sciences and technology veteran, with 35 years of global leadership experience emphasizing the following:- Global, multi-disciplinary, and multi-industry leadership, with a heavy focus on both establishment of and execution against strategic and functional goals;- Establishment, defense, and remediation of Quality Management Systems (QMSs) in a variety of domestic and international regulatory settings including effective interactions with regulatory authorities and notified bodies;- Organizational process improvement initiatives;- Methodical establishment and growth of high-performance organizations;- Wide-ranging functional expertise in high technology medical devices (e.g., SiMD, SaMD) including AI/ML-enabled devices;- Advising corporate management, boards, and public-private partnership leaders on regulatory requirements and compliance strategies;- Execution of regulatory due diligence for M&A; and- Application of global regulations, standards, and guidance in life science business operations.
Quality Champions For Life
View- Website:
- qualitychampions.org
- Employees:
- 5
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Adjunct FacultyQuality Champions For LifeCleveland, Oh, Us
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Pathway Adjunct FacultyPathway For Patient HealthCleveland, Oh, Us -
Senior Quality & Regulatory Compliance Advisor, Fda & Life Sciences PracticeKing & Spalding Nov 2018 - PresentAtlanta, Ga, UsProvide advisory and management consulting services focused on regulatory compliance, enforcement, and policy matters involving industries regulated by the FDA and other global life sciences regulatory competent authorities. Advise corporate management, boards, and staff concerning their responsibilities, regulatory expectations, and how to navigate through compliance and enforcement complexities during crisis events.Specific areas of focus include the following:- Quality and Regulatory organizational structure and execution;- QMS establishment, remediation, and defense;- Applicability of global regulations, standards, and guidance;- Audit / inspection preparation, management, and response;- FDA, competent authority, and notified body interactions;- Compliance-related due diligence reviews (e.g., M&A);- Regulatory frameworks for effective cybersecurity (includes engagement as Interim Chief Product Security Officer);- Regulatory frameworks for artificial intelligence / machine learning (AI / ML) systems;- Engagement with public-private industry committees, interest groups, and regulatory collaborative communities;- Expert witness in FDA compliance-related litigation; and- Internal investigations. -
Pathway Adjunct FacultyPathway For Patient Health Aug 2022 - PresentMason, Ohio, UsLectures and course development work for undergraduate students, graduate students, and industry professionals (includes FDA and global regulatory overview, risk management, software design controls, medical device design controls, non-device software validation, and digital health - software as a medical device)
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Adjunct Lecturer, Ra/Qa Graduate ProgramTemple University School Of Pharmacy Dec 2020 - Dec 2020Philadelphia, Pennsylvania, UsLectures addressed Computer Software Validation (CSV), impact analysis, and regulatory enforcement. -
Global Head Of Qa/Qe, Diagnostic Imaging Business GroupPhilips Nov 2014 - Nov 2018Amsterdam, Noord-Holland, NlLed Quality Assurance and Quality Engineering for the Diagnostic Imaging Business Group (14 sites in 8 countries) including:- CT- Advanced Molecular Imaging- MRI- Diagnostic X-Ray- Mammography- GTC (Generators, Tubes, and Components)- Radiology Solutions -
Director, Design Quality AssuranceMedtronic Jun 2012 - Nov 2014Minneapolis, Mn, UsDiabetes Business Unit----------- Design Assurance (SW Quality, HW Quality, System Verification)- Internal Audit- Inspection / Audit Management- QMS Remediation (specifically design controls and inspection management)- Information Security Advisory Committee -
Global Software Design Controls ManagerGe Healthcare Jun 2010 - Jun 2012Chicago, Us- Software design controls process / tools- Design controls effectiveness program- Inspection / audit support- Agile steering committee -
Sr. Manager, Enterprise Systems And Clinical Software QualityBoston Scientific Sep 2007 - Jun 2010Marlborough, Ma, Us -
Manager, Design AssuranceHologic Jul 2002 - Sep 2007Marlborough, Ma, Us -
Practice Director, Software QualitySpherion Dec 2000 - Nov 2002Atlanta, Georgia, Us -
Director, Development ServicesUltraprise Oct 1999 - Dec 2000- Software Testing- Software Configuration Management- Requirements Management- Technical Writing
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Director, Test ManagementNasd (Now Finra) Apr 1997 - Oct 1999- Software Testing (NASD, NASD Regulation, NASD Market Systems)- CMM ML 2 & 3 Appraisal- Y2K Program Director- American Stock Exchange Acquisition Due Diligence- Process Improvement Oversight Committee & various Process Action Teams
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Sr. Quality Assurance Analyst / Team LeadAmisys Managed Care Systems Jul 1996 - Apr 1997
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Business AnalystHechinger Aug 1995 - Jul 1996
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VariousLowe'S Jan 1986 - Jul 1995Mooresville, Nc, UsVarious Store Systems and Store Operations practitioner and leadership positions
Eric Henry Skills
Eric Henry Education Details
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Wilmington UniversityBusiness Administration / Organizational Management -
Texas A&M University
Frequently Asked Questions about Eric Henry
What company does Eric Henry work for?
Eric Henry works for Quality Champions For Life
What is Eric Henry's role at the current company?
Eric Henry's current role is Adjunct Faculty.
What is Eric Henry's email address?
Eric Henry's email address is er****@****ips.com
What is Eric Henry's direct phone number?
Eric Henry's direct phone number is (800) 682*****
What schools did Eric Henry attend?
Eric Henry attended Wilmington University, Texas A&m University.
What are some of Eric Henry's interests?
Eric Henry has interest in Reading, Home Improvement, Automobiles, Electronics.
What skills is Eric Henry known for?
Eric Henry has skills like Quality Assurance, Fda, Cross Functional Team Leadership, Medical Devices, Iso 13485, Quality System, Process Improvement, Testing, Design Control, Validation, Software Quality Assurance, Capa.
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