As a Site Quality Manager you will be directly responsible for the quality operations for the Fort Myers site. The Site Quality Manager under supervision of the Corporate Director of Quality, will partner with Pharma & Clinical Division functional leaders to ensure effective and appropriate operations and to drive a world-class quality culture with continuous improvement in systems, processes, mindsets, and behaviors
• Vision & Strategy: The Site Quality Manager will provides oversight and leadership to the Pharma & Clinical Division laboratory operations ensuring adherence to and driving improvements to the Quality Management systems (QMS).
• Compliance: Ensures continual assessment of QMS data and on-going operations to ensure appropriate execution to company policies and procedures and regulatory requirements per CAP/CLIA, NY State, ISO 15189/13485, FDA 21CFR820
• Customer focus: Partner with external and internal customers to ensure resolution and communication of quality issues, data streams are provided, internalized and acted upon to ensure world-class quality performance.
• External Audits: Responsible for supporting the external and internal auditing activities and plans, and representing the quality operations to the auditor.
• Non-Conformance Management: Responsible for supporting the organization with root-cause analysis, corrective/preventive effectiveness checks verification and validation to execute complex CAPAs.
• Timely completion and follow up through to closure of CAPA actions.
• Provide the team with guidance on how to gather investigations within Non-Conformance Management System.
• Process Improvement: The Site Quality Manager will partner with Pharma & Clinical Division functional leaders to identify key quality performance projects and implement systemic improvements and standards that will reduce customer complaints, non-conformances, compliance with Quality, business requirements, and improve quality performance.
• Actively participate and/or drives US/EU/Global QMS improvements as required.
• Quality Metrics: Measuring and monitoring of performance against agreed KPIs.
• Collate and share information / data across the site as appropriate through reports and follows up on identified improvement opportunities.
• Support reporting of key related metrics on quality risks, issues, initiatives, and projects at cross-functional meetings and shares new and or/revisions to regulatory requirements as defined by NeoGenomics Quality Management Director and the leadership team.
Experience & Required Qualifications:
• Education: Bachelor’s degree in Biology/Biological Sciences, or related field, or equivalent years of significant Quality Management experience
• Experience: 3-5 years of experience in laboratory regulations Quality Assurance (QA) management role in a regulated environment (FDA, ISO13485, CAP/CLIA); for internal candidates, at least one year of NeoGenomics experience is required
• Quality and/or Regulatory Affairs certification desirable (e.g. CQM, CQE, CQA, RAC).
• This is a “hands on” position where extremely high attention to detail, creation and management of documentation/projects is required
• Excellent understanding of FDA and ISO regulations in relation to Design Controls, Risk Management, and QSR 820
• Experience working with external auditing agencies
• Experience with Electronic Document Control and Software
• Performance and Results, Customer Focus and Integrity
• Demonstrated ability to work collaboratively in a cross-functional, cross-discipline environment
• Demonstrated success in a position requiring highly effective communication, facilitation and negotiation skills
• Be open minded, collaborative and able to work in a non-hierarchical environment
• Ability to look at processes high level as well as zoom in on a detailed level
• Project management skills preferred.