John Lockwood
Sr Director, Head of Medical Device Ivd, Americas @PharmaLex
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WORK HISTORY
Sr Director, Head of Medical Device Ivd, Americas @PharmaLex
Burlington, MA, US
EDUCATION
University of Illinois Urbana-Champaign
BS, Chemistry
ABOUT JOHN LOCKWOOD
Senior Quality / Regulatory / Organizational Leader responsible for the implementation of quality systems, methodologies, assessments, and performance management. Expertise includes the proficiency to:• Drive teams to ensure the development and implementation of best practices across all suppliers.• Obtain robust and timely responses for quality issues to quickly resolve incidents and systemic issues.• Provide leadership to team members to ensure compliance with FDA, ICH, ISO, and other regulatory requirements.• Assign resources, lead, and facilitate supplier quality improvement programs, projects, and activities.• Direct validation and qualification activities in a regulated environment, • Interact directly with FDA inspectors• Develop regulatory documentation for FDA and EU regulated products• Lead internal and external audit activities against FDA GxP regulations, ISO 9001, ISO 13485, ISO 17025, ISO 15189, and CAP/CLIA.Specialties: quality management systems, design control methodologies, supply chain assessments, device and diagnostic product development, method validation, reagent manufacturing, and quality assurance.
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