Stephanie Grebe

Experience

1. Associate Director, Quality and Compliance

   Thread

   Nov 2019 — Present · Raleigh-Durham, NC, US

   Work across the organization to develop and implement changes to improve quality processes and documentation within the organization.\\\\n• Manage ongoing process improvement projects and relationships across the organization with other business groups such as Product, Operations, Delivery, Support, and Technology.\\\\n• Enforce compliance with global regulations for THREAD products from requirements gathering to post-release activities.\\\\n• Quality planning and oversight; including technical and non-technical risk assessments.\\\\n• Plan and execute internal audit schedule of IT and systems; publish audit reports and work with Teams to implement agreed to CAPAs.\\\\n• Create and maintain policies and standard operating procedures (SOPs).\\\\n• Maintain awareness and act as needed to assure compliance with applicable regulations and standards; both domestic and internationally.\\\\n• Plan, host and document regulatory inspections and sponsor audits; document and manage related reports. Manage CAPAs and effectiveness checks.\\\\n• Assess and manage quality aspects of vendors through THREAD’s vendor management program.\\\\n• Address quality issues and complaints reported both internally and externally.\\\\n• Manage Compliance and Quality team.\\\\n• Train and maintain training records for all staff on SOPs, GCPs, and applicable regulatory standards/ guidelines.\\\\n• Address reports of noncompliance or suspected noncompliance with applicable standards.\\\\n• Coordinate and conduct internal audits of THREAD services and/or products.\\\\n• Conduct quality investigations to via root cause analyses. Track and manage associated CAPAs.\\\\n• Develop and track key performance indicators for Compliance and Quality including tracking and notification of quality issues and incidents.\\\\n• Track and trend quality data to improve QMS.\\\\n• Provide quality expertise and assistance to business development and all functional areas as requested.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n

Education

• Michigan State University

  Bachelor of Science (BS), Medical Technology