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Vice President of Quality & Regulatory Affairs

Company: NeoGenomics
Location: Fort Myers
Posted on: September 18, 2022

Job Description:

Are you motivated to participate in a dynamic, multi-tasking environment? Do you want to become part of a company that invests in its employees? Are you seeking a position where you can use your skills while continuing to be challenged and learn? Then we encourage you to dive deeper into this opportunity.NeoGenomics is looking for a Vice President of Quality who wants to continue to learn in order to allow our company to grow.Now that you know what we're looking for in talent, let us tell you why you'd want to work at NeoGenomics:As an employer, we promise to provide you with a purpose driven mission in which you have the opportunity to save lives by improving patient care through the notable work you perform. Together, we will become the world's leading cancer reference laboratory.Position Summary:The Vice President of Quality and Regulatory will directly report to the SVP of Laboratory operations or Executive, and will be responsible for implementing and managing Quality Operation functions and interfacing with Operations (Commercial), Pharma Services, Quality Assurance (QA), Information technology (IT), Medical, Compliance and Senior Management. This position is to assure that all functions, services, and processes are followed in accordance with NeoGenomics Laboratory and Regulatory standards.Core Responsibilities

  • Knowledgeable of Federal and State laws and regulations concerning clinical laboratory testing procedures and results.
  • Vision & Strategy: Provides oversight, direction, and input to implementation of Quality Management Systems and assists the leadership team in communicating that vision with internal and external customers.
  • Customer focus: Improve internal and external customer experience regarding quality and long term reliability by working with site leaders and cross functional teams to identify issues, drive root cause analysis and implement robust corrective actions. This will involve strong cross-functional skills to arrive at a consensus as to most effective solution and implementation plan.
  • Quality Management Standards: Working in conjunction with the Senior Leadership to implement a quality strategy that ensures the Laboratory is in compliance with all regulatory requirements, ensuring implementation of GCP/GLP/Compliance related IR's for key process areas, emerging trends, and areas of high impact using a risk-based approach from audits and inspections.
  • International Quality Standards. Build and implement ISO 15189 and ISO 13485 quality systems at NeoGenomics facilities used to support clinical trials and for clinical use.Requirements
    • Education: Bachelor of Science in healthcare field, strong preference for PhD level. Masters degree (MBA) a plus
    • 15+ years of related Laboratory/Pharmaceutical/Medical Device industry experience including at least 5+ years of document and process quality management and/or quality assurance experience.
    • Knowledge of regulations and standards affecting Laboratory diagnostics and Pharma.
    • Prior experience, knowledge and understanding of regulations regarding CAP, CLIA, ISO 15189, ISO 13485, MOH (Ministry of Health), and FDA certifications, accreditations, audits, inspections and regulatory submissions, in particular FDA PMA submissions and approvals.
    • Understand the requirements for international standards including IVDR timelines and compliance.
    • Demonstrated Quality related leadership and management responsibilities.
    • In depth proven experience in quality related management position with a track record of success in implementing Quality Management Systems Programs.
    • Proven experience in supporting QMS programs development including SOP preparation and lifecycle management, identification of functional group procedural needs (Gap analyses).

Keywords: NeoGenomics, Fort Myers , Vice President of Quality & Regulatory Affairs, Executive , Fort Myers, Florida

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